Management of Rotator Cuff Injuries
Endorsed by: AANA, ASES, AOSSM, ASSET, APTA
Management of Small to Medium Tears
Strong evidence supports that both physical therapy and operative treatment result in significant improvement in patient-reported outcomes for patients with symptomatic small to medium full-thickness rotator cuff tears.
Strong Evidence Strong Evidence
Two prospective randomized controlled trials comparing physical therapy to operative repair for treatment of small to medium rotator cuff tears showed substantial improvement in patient reported outcomes (PROs)and strength over time; however, there were no clinically meaningful difference in PROs between the groups. (Moosmayer, 2014, Kukkonen 2015) At 5-year follow up, Moosmayer, et.al., reported that the results of primary repair were superior to physical therapy, with the mean group differences of 5.3 for the Constant score (p=0.05) and 9.0 for the ASES score (p<0.001); however, the differences in PROs were below the accepted minimal clinically important difference. (Moosmayer 2014) Both physical therapy and operative repair groups demonstrated clinically meaningful improvement from baseline in the Constant score, ASES score, SF-36 score, and strength. (Moosmayer 2014) At 2-years, Kukkonen, et.al., reported no significant (p=0.38) differences in the mean change of the Constant score between physical therapy and repair, both treatments resulted in substantial clinical improvement from pre-to-post treatment. (Kukkonen 2015)

Risks and Harms of Implementing this Recommendation
There are no harms in associated in implementing this recommendation. There were no reported statistical differences between primary or secondary repair, when physical therapy fails (p=0.23). (Moosmayer S 2014)

Future Research
Continued comparative studies between physical therapy and surgical repair investigating larger tear sizes and modern approaches and fixation methods. The studies need to continue beyond 5-years to fully understand the true efficacy of each treatment.
Long Term Non-Operative Management
Strong evidence supports that patient reported outcomes (PRO) improve with physical therapy in symptomatic patients with full thickness rotator cuff tears. However, the rotator cuff tear size, muscle atrophy, and fatty infiltration may progress over 5 to 10 years with non operative management.
Strong Evidence Strong Evidence
Two prospective randomized controlled trials comparing physical therapy to operative repair for treatment of small to medium rotator cuff tears have showed that physical therapy can result in clinical improvements, but the rotator cuff tears continue to enlarge with time. (Moosmayer 2014, Kukkonen 2015) In 37% of the rotator cuff tears treated with physical therapy in whom the tear size increased > 5 mm over five years; tear progression did not occur (0/60) in the repaired group (Moosmayer 2014) At 2-years, Kukkonen, et.al., reported that the tears treated with physical therapy instructed home exercise program enlarged from an average of 9.6 mm to 11.7 mm, while the repaired tendons tear size decreased from 8.4 mm to 4.2 mm (p<0.01). (Kukkonen 2015) After an average of 8.8 years, patients who were treated non-operatively showed substantial muscle atrophy in 49% (18/37) and fatty infiltration in 41% (15/37). (Moosmayer 2017)

Risks and Harms of Implementing this Recommendation
Patients treated non-operatively are at risk for reduced strength with rotator cuff tear progression. Moosmayer, et.al., compared patients treated with physical therapy that had an increase the tear size ≤ 5mm to those that progressed to > 5mm and reported the > 5mm group showed a loss of strength (between-group difference of 4.2 kg, p=0.02). (Moosmayer 2014) In a prospective cohort study, the Constant score was 81points for patients with tear size increases < 20 mm compared to 58.5 points in those ≥ 20 mm (p=0.008). (Moosmayer 2017) Patients who select physical therapy should be informed that over a 9 year period their tear size may progress and this could lead to a substantial decline in their perceived and measurable outcome.

Future Research
Continued long term comparative studies between physical therapy and surgical repair investigating larger tear sizes with pre-and postoperative advanced imaging studies. It is still unclear what factors influence tear progression and if tear progression advances enough to preclude future repair and subsequent resolution of symptoms.
Operative Management
Moderate evidence supports that healed rotator cuff repairs show improved patient-reported and functional outcomes compared to physical therapy and unhealed rotator cuff repairs.
Moderate Evidence Moderate Evidence
In a 1-year prospective randomized controlled trial (RCT) comparing physical therapy to surgical repair for treatment of small to massive rotator cuff tears, Lambers Heerspink, et.al., reported a superior Constant score for intact repairs (88.5) compared to physical therapy (75.6, p<0.05) and re-tears (73.2). (Lambers Heerspink 2015) A 5-year prospective RCT of small to medium sized rotator cuff tears comparing physical therapy with an option of surgical treatment (what the authors termed secondary surgery) to primary surgical repair reported that 24% (12/51) patients failed to substantially improve their Constant score (mean increase of 1.8 points) with physical therapy and opted for surgical repair within the first two years. (Moosmayer 2014). The post hoc as-treated analysis comparing primary tendon repair, physical therapy only, and secondary surgery after failed physical therapy showed a significantly larger Constant score in favor of primary repair over physical therapy (between-group difference of 9.7 points, p=0.006), but no significant difference between primary and secondary tendon repair (p=0.23). (Moosmayer 2014) At 5 years, re-tears were diagnosed by ultrasound in 25% (15/60) of the patients; 7 partial and 8 full thickness tears. The partial thickness tears showed significant inferior results compared to intact repairs (mean Constant score difference of 23.1 points, p=0.001); full thickness tears demonstrated no difference in Constant score compared to intact repairs (p=0.92). (Moosmayer 2014) However, in a level II cross-sectional study, healed rotator cuff repairs compared to full thickness re-tears showed significant improvement in the ASES and SST scores; intact ASES 91, SST 10.2 verses full-thickness defect ASES 69, SST 6.5 (p<0.01). (Kim 2014)

Risks and Harms of Implementing this Recommendation
There are no harms in associated in implementing this recommendation. There were no reported statistical differences between primary or secondary repair, when physical therapy fails (p=0.23). (Moosmayer 2014)

Future Research
Continued long term comparative studies between physical therapy and surgical repair investigating larger tear sizes with pre-and postoperative advanced imaging studies. The long-term consequences of a persistent rotator cuff tear or a re-tear is currently not known.
Acromioplasty & Rotator Cuff Repair
Moderate strength evidence does not support the routine use of acromioplasty as a concomitant treatment as compared to arthroscopic repair alone for patients with small to medium sized full-thickness rotator cuff tears.
Moderate Evidence Moderate Evidence
Five high quality studies (Abrams, G. 2014; Garstman, G. 2004; MacDonald, P. 2011; Milano, G. 2007; Shin S. 2012) evaluated the effect of acromioplasty on rotator cuff repair of small and medium sized tears. Overall, acromioplasty did not have an effect on outcomes with the exception of one study which found a higher reoperation rate in patients without acromioplasty. Gartsman, et al. performed a randomized study on patients with supraspinatus tears and Type 2 acromions, with no difference in outcome.  Milano, et al. randomized 80 patients and similarly found no difference in outcomes after 2 years.  Abrams, et al. evaluated 52 patients, and also found no difference between groups.  Shin, et al. similarly found no differences in randomized groups with varying acromial morphology included in both groups.

MacDonald, et al. evaluated 86 randomized patients with and without acomioplasty and also found no difference in patients reported outcomes, however, there was a higher reoperation rate in the group without acromioplasty.  Four of the patients subsequently had second surgery for acromioplasty.  One had a type 2 acromion and the others had type 3 acromions.

Risks and Harms of Implementing this Recommendation
There are no harms in associated in implementing this recommendation. There were no reported statistical differences between primary or secondary repair, when physical therapy fails (p=0.23). (Moosmayer S 2014)

Future Research
Continued long term comparative studies between physical therapy and surgical repair investigating larger tear sizes with pre-and postoperative advanced imaging studies. The long-term consequences of a persistent rotator cuff tear or a re-tear is currently not known.
Distal Clavicle Resection
Moderate strength evidence supports the use of distal clavicle resection as a concomitant treatment to arthroscopic repair for patients with full-thickness rotator cuff tears and symptomatic acromioclavicular joints.
Moderate Evidence Moderate Evidence
Two studies (Oh, J. 2014 and Park, Y. 2015) showed no difference in patients with and without distal clavicle resection. One study (Oh) included patients with symptomatic AC joint arthrosis, and while the outcomes were the same, a distal clavicle resection resulted in symptomatic instability in a small number.

Another study (Kim, J. 2011) studied the use of DCR in asymptomatic AC joint arthrosis however, this study may not be generalizable to most patients as this included patients with asymptomatic AC joints with inferior spurs.

Risks and Harms of Implementing this Recommendation
There is no known harm to patients by implementing this recommendation, but there could potentially be a slightly higher reoperation rate on patients who did not undergo the concomitant procedures.

Future Research
Future research could be performed to elucidate risk factors for reoperation rates in certain groups who did not undergo concomitant procedures.
Diagnosis (Clinical Examination)
Strong evidence supports that clinical examination can be useful to diagnose or stratify patients with rotator cuff tears; however, combination of tests will increase diagnostic accuracy.
Strong Evidence Strong Evidence
Evidence from 8 high quality studies (Liu 2016, Lin 2015, Castoldi 2009, Park 2005, Litaker 2000, Villafane 2015, Holtby 2004, Gillooly 2010) indicate that the following tests are useful to diagnosis full-thickness rotator cuff tear:  bear hug test, belly press test, empty can test, external rotator lag sign, external rotation resistance test, full can test, Hawkins test, Hug up test, internal rotation lag sign (IRLS) test, internal rotation resistance test (IRRT) test, Internal rotation resistance test at maximal 90 degrees of abduction and maximal external rotation (IRRTM) test, Jobe Test, Lateral Jobe Test, Lift off test, NEER test, Patte Test, and Yocum test.  Generally, these tests are better to diagnose (rule in), than screening (rule out) full thickness rotator cuff tears.

Bear hug test summary
Combined full/partial thickness tears:
One high quality study evaluated the bear hug test to diagnose any rotator cuff tear (Lin 2015). The test results produce a small but sometimes important change in probability of rotator cuff tears (positive LR=3.49, negative LR=0.37).

Belly press test summary
Combined full/partial thickness tears:
One high quality study evaluated the belly press test to diagnose any rotator cuff tear (Lin 2015). The test results produce a small, but sometimes important change in the probability of a tear (positive LR=3.18, negative LR=0.45).

Empty can test summary
Combined full/partial thickness tears:
One high quality study evaluated the empty can test for diagnosing any rotator cuff tear (Liu 2016). The test results produce a small, but sometimes important change in the probability of a tear (positive LR=3.30, negative LR=0.21).

External rotator lag sign summary
Partial Thickness Tears:
One high quality study evaluated the external rotator lag sign test to diagnose partial thickness tears(Castoldi 2009). A positive test resulted in a moderate sized increase in probability of a partial thickness tear (positive likelihood ratio(LR)= 6.44). However, the test was poor for ruling out partial thickness tears, with a negative test producing a very small decrease in probability of a partial thickness tear(negative LR=0.89).

External Rotation Resistance Test (Resisted ER).
One high quality (Park 2005) and one low quality (Litaker 2000) evaluated External Rotation Resistance Test.

Full thickness tear:
Park found that resisted ER maybe useful for ruling in full thickness tears (positive LR=3.16), but was poor at ruling them out (negative LR=0.59).

Partial Thickness Tear:
Park found resisted ER to be poor at ruling in and ruling out partial tears (positive LR=0.63 negative LR=1.17).

Combined partial and full thickness:
Litaker found resisted ER to be a poor rule-in test(positive LR=1.78) in diagnosing combined full/partial thickness tears, but may be somewhat useful for ruling out tears Negative LR=0.42).

Full Can Test summary
Combined full/partial thickness tears:
One high quality study evaluated the full can test to diagnose any rotator cuff tear (Liu 2016). The test results produce a small, but sometimes important change in the probability of a tear (positive LR=4.10, negative LR=0.27).

Hawkins Test summary
Two high quality studies and one low quality study evaluated the Hawkins test (Liu 2016,Villafane 2015, Park 2005).

Combined full/partial thickness tears:
Liu used the test to diagnose any rotator cuff tear, and found a positive test produced a small, but sometimes important increase in probability of a tear with a positive test (positive LR=2.82). However, the same study found it was a poor test for ruling out a tear (negative LR=0.73).

Full Thickness Tears:
A moderate quality study by Park(2005) found the Hawkins test to be poor at ruling in and ruling out full thickness tears (Positive LR=1.33, negative LR=0.65).

Partial Thickness Tears:
The Villafane (2015) study used the test to diagnose partial tears.. A positive test produced a large and conclusive increase in probability of a partial tear (positive LR=10.25), and a negative test produced a moderate decrease in probability of a partial tear(negative LR=0.20). However, a moderate quality study by Park (2005) found the test to be poor at both ruling in and ruling out a partial tear (positive LR=1.36, negative LR=0.55).

Hug up test summary
Combined full/partial thickness tears:
One high quality study evaluated the hug up test for diagnosis of any rotator cuff tear (Liu 2016). A positive test produced a small, but sometimes important increase in probability of a tear (positive LR=4.02), and a negative test produced a large decrease in probability of a tear (negative LR=0.08).

Internal Rotation Lag Sign (IRLS) test summary
Combined full/partial thickness tears:
One high quality study evaluated the IRLS test to diagnose any rotator cuff tear(Lin 2015). A positive test produced a small, but sometimes important increase in probability of a tear(positive LR=4.21). The test was poor for ruling out a tear, with a negative test producing a very small decrease in probability of a tear(negative LR=0.74).

Internal rotation resistance test (IRRT) test summary
Combined full/partial thickness tears:
One high quality study (Lin 2015) evaluated the IRRT test to diagnose any rotator cuff tear. A positive test produced a small, but sometimes important increase in probability of a tear (Positive LR=2.59). However, it was a poor rule out test (negative LR=0.51).

Internal rotation resistance test at maximal 90 degrees of abduction and maximal external rotation (IRRTM) test summary
Combined full/partial thickness tears:
One high quality study evaluated the IRRTM test to diagnose any rotator cuff tear (Lin 2015). Both positive and negative test results produced a small, but sometimes important change in probability of any rotator cuff tear (positive LR=3.91, negative LR=0.29).

Jobe Test summary
Two high quality studies evaluated the Jobe test (Holtby 2004,Villafane 2015) for FTT and PTT tears.

Full-Thickness Tears : Holtby(2004) was the only study to specifically evaluate full thickness tears. The study found the test results produced a very low change in probability of a full-thickness tear(positive LR=1.36, negative LR=0.84).

Partial-Thickness Tears: Two studies evaluated the Jobe test for diagnosing a partial tear (Holtby 2004,Villafane 2015). The results were varied between the two studies. The rule in test strength ranged from poor (positive LR=1.34, Holtby 2004) to moderately strong (positive LR=9.50, Villafane 2015). The Villafane study found that a negative test produced a small, but sometimes important decrease in probability of a partial tear(negative LR=0.26). However, the Holtby study found the test to be poor at ruling out a partial tear (negative LR=0.71).

Lateral Jobe Test Summary
Combined full/partial thickness tears:
Gillooly(2010) found the Lateral Jobe test to be moderately good at ruling in any tear (positive LR=7.43), and a negative test produced a small but sometimes important decrease in probability of a tear(negative LR=0.21). The same study evaluated the Lateral Jobe test when combined with other physical exams, and found the test results produced a small but sometimes important change in probability of a tear(positive LR=4.69, negative LR= 0.48).

Lift off test summary
Combined full/partial thickness tears:
Lin(2015, high quality) evaluated the lift off test for diagnosing any rotator cuff tear. The test was poor at ruling in and ruling out a tear (positive LR=1.92, negative LR=0.58).

NEER test summary
Three high quality studies and one moderate quality study evaluated the Neer test (Liu 2016,Villafane 2015, Park 2005). Liu tested for any rotator cuff tear, Villafane tested for partial tears, and Park stratified by tear size.

Combined full/partial thickness tears:
Liu found the test to be moderately strong at ruling in any tear (positive LR=5.90), and may be useful for ruling out any tear (negative LR=0.42).

Full Thickness Tear:
Park evaluated the tests ability to diagnose full thickness tears. The study found the test was poor at both ruling in and ruling out full tears (positive LR=1.12, negative LR=0.86).

Partial Thickness Tears:
The Villafane and Park studies evaluated the neer test for diagnosing partial tears. As a rule in test, the results were inconsistent between studies. Villafane found the test to be moderately strong at ruling in partial tears (positive LR=7.00), but Park found it to be poor at ruling in a tear (positive LR=1.44). Both studies showed the test to be poor at ruling out partial tears (negative LR range=0.52-0.75).

Patte Test summary
Partial Thickness Tears:
One high quality study evaluated the Patte test to diagnose a partial tear (Villafane 2015).  A positive test result produced a large and conclusive increase in probability of a partial tear(positive LR=19.0). However, it was a poor rule out test (negative LR=0.63).

Yocum test summary
Partial Thickness Tears:
One high quality study evaluated the Yocum test for partial tears (Villafane 2015). A positive test result produced a large and conclusive increase in probability of a partial tear (positive LR=19.5). A negative test produced a small, but sometimes important decrease in probability of a partial tear (negative lr=0.23).

Risks and Harms of Implementing this Recommendation
There is no known harm to patients by implementing this recommendation, but there could potentially be a slightly higher reoperation rate on patients who did not undergo the concomitant procedures.

Future Research
Future research could be performed to elucidate risk factors for reoperation rates in certain groups who did not undergo concomitant procedures.
 
Diagnosis (Imaging)
Strong evidence supports that MRI, MRA, and ultrasound are useful adjuncts to a clinical exam for identifying rotator cuff tears.
Strong Evidence Strong Evidence
Ultrasound
Six high quality studies evaluated the use of ultrasound for diagnosing rotator cuff tears (Cheng 2015, Day 2016, Gormeli 2014, Moosmayer 2007, Ok 2013, Waldt 2007).

Four of the studies tested for the presence of any rotator cuff tear (full/partial thickness) vs no tear (Day 2016, Gormeli 2014, Moosmayer 2007, Waldt 2007). A meta-analysis of these four studies was conducted (see figures 1 and 2 for ROC curve and forest plot in eAppendix 2). The pooled positive LR was 3.60 (2.10,6.00) indicating that a positive result produced a small, but sometimes important increase in probability of a tear. The confidence interval for this pooled effect crosses 5(the threshold for a moderate effect), so we cannot rule out the possibility that the test is of moderate strength for ruling in a tear.  The pooled estimate of the negative LR revealed substantial heterogeneity, with an I-squared of 50.10%. Therefore, only the range of negative LRs from the included studies are reported in the summary of findings tables. Negative LRs ranged from 0.07 (indicating a strong rule-out test) to 0.53 (indicating a poor rule out test).

Four studies evaluated the ability of ultrasound to distinguish between full thickness tears and either partial or no tear (Cheng 2015, Gormeli 2014, Ok 2013, Waldt 2007). A meta-analysis of positive and negative LRs produced consistent estimates, with I squared heterogeneities of 0 and 22.15%. The Meta-Analysis ROC curves and forest plots can be found in figures 3 and 4. A positive ultrasound test produced a moderate increase in probability of full thickness tears vs partial/no tears (pooled positive LR=5.20 (3.20,8.20)).  A negative test produced a small, but sometimes important decrease in the probability a patient did not have a full thickness tear, but instead either had a partial tear or no tear (negative LR=0.28 (0.20,0.38)).

Magnetic Resonance Arthrography (MRA)
12 high quality studies tested MRA for the diagnosis of rotator cuff tears. (Anbar 2015, Dae 2009, Duc 2006, Lee 2018, Magee 2014, Magee 2016, Ok 2013, Pfirrmann 1999, Probyn 2007, Schaeffeler 2012, Schreinemachers 2009, Waldt 2007).

Five studies used MRA to distinguish between any tear (full/partial thickness) and no tear (Dae 2009, Pfirrmann 1999, Probyn 2007, Schaeffeler 2012, Schreinemachers 2009). A meta-analysis was attempted, but pooled estimates of positive and negative LRs revealed substantial heterogeneity, with I squared statistics of 85.16 and 80.33% respectively. Therefore, the range of positive and negative LRs are presented, rather than the pooled estimates. The positive LRs ranged from 1.6 (poor test) to 53.57 (Strong test) for ruling in any tear vs no tear. The negative LRs ranged from 0 (strong test) to 0.65 (poor test) for ruling out any tear vs no tear. Given these results, MRA may provide a benefit for diagnosing any tear, but the exact strength of the test is unclear given widely heterogeneous results between studies.

Four studies tested the ability of MRA to distinguish between full thickness tears and partial or no tears (Duc 2006, Lee 2018, Ok 2013, Waldt 2007). A meta-analysis was conducted(see figures 5 and 6 for ROC curve and forest plot). The meta-analysis produced consistent estimates of the positive LR, indicating that a positive MRA test for full thickness tears produced a large increase in probability that a patient truly had a full tear instead of a partial or no tear (pooled positive LR= 19.55 (5.73,55.72)). Pooled estimates for the negative LR had high heterogeneity (I squared=91.15%), so the pooled result is not reported. The negative LR in the included studies ranged from 0 (strong rule out test) to 0.68 (poor rule out test).

Three studies tested the ability of MRA to distinguish between a full thickness tear and no tear (Anbar 2015, Magee 2014, Magee 2016). These could not be meta-analyzed because a minimum of four studies is required. A positive test produced a moderate to large increase in probability of a full thickness tear versus no tear(positive LR range=7.33 to 100). The negative LR was more variable, ranging from 0(a strong decrease in probability of a full tear with a negative test) to 0.25(a small but sometimes important decrease in probability).

Two studies evaluated MRA for diagnosing partial tears vs no tears (Dae 2009, Lee 2018). Positive LRs ranged from a small(but sometimes important) increase in probability of a partial tear with a positive test (positive LR=4.16) to a large increase in probability of tear(positive LR=13.42).   Negative LRs ranged from a strong decrease in probability of a partial tear with a negative test(negative LR=0.03), to a small but sometimes important decrease in probability of a partial tear(negative LR=0.44).

Magnetic Resonance Imaging (MRI)
Thirteen high quality studies evaluated MRI for the diagnosis of rotator cuff tears (Binkert 2001, Herold 2006, Lee 2016, Lee 2018, Magee 2014, Magee 2016, Mohtadi 2004, Razmjou 2016, Ryu 2016, Shellock 2001, Tuite 1994, VanBeek 2014, Yildiz2017).

Seven studies used MRI to test for any rotator cuff tear(full or partial thickness) versus no tear (Herold 2006, Lee 2018, Ryu 2016, Shellock 2001, Tuite 1994, VanBeek 2014, Yildiz 2017).  An attempt was made to meta-analyze these studies, but there was very high heterogeneity in estimates of the positive and negative LRs between studies (I squared=91.94% and 91.8% respectively). Therefore, only the range of estimates from the studies is reported.  The positive likelihood ratios ranged from 1.18(poor rule in test) to 97.06 (strong rule in test).  The negative LRs also ranged from a strong rule out test (negative LR=0.03) to a poor rule out test (0.79).

Six high quality studies used MRI to distinguish full thickness tears from no tear (Binkert 2001, Magee 2014, Magee 2016, Mohtadi 2004, Razmjou 2016, Tuite 1994). Again, meta-analysis results revealed high heterogeneity, and likelihood ratio ranges are presented here. The studies indicated that MRI was a moderate to strong test for ruling in a full thickness tear over no tear (positive LR range=6.82-100). The negative LR ranged from a large decrease in probability of a full tear with a negative test (negative LR=0) to a small, but sometimes important decrease in probability of a full tear(negative LR=0.47).

Five studies evaluated the ability of MRI to distinguish between partial tears versus no tear. A meta-analysis produced consistent estimates of the positive LR, but negative LRs were inconsistent between studies. The ROC curve and forest plot can be found in figures 7 and 8. The pooled positive LR was 3.40 (2.10,5.40), indicating that a positive MRI produced a small, but sometimes important increase in probability of a partial tear.  The negative LR ranged from 0.27 (a small but possibly important decrease in probability of a partial tear with a negative test) to 0.84 (a poor rule out test).
Post-Op Mobilization Timing
Strong evidence suggests similar postoperative clinical and patient-reported outcomes for small to medium sized full-thickness rotator cuff tears between early mobilization and delayed mobilization up to 8 weeks for patients who have undergone arthroscopic rotator cuff repair.
Strong Evidence Strong Evidence
Six high quality randomized controlled trials (Cuff, D. 2012; De Roo, P. 2015; Duzgun, I. 2014; Keener, J. 2014; Koh, K. 2014; Mazzocca, A. 2017) evaluated post-operative mobilization paradigms following rotator cuff repair. All 6 studies compared the outcomes of patients who began mobilization exercises of their shoulder within 0-2 weeks post-operatively against patients who delayed mobilization exercises for between 4-8 weeks post-operatively.   In each of the reviewed studies, patients were immobilized in a sling for an equivalent length of time irrespective of group assignment. The consistency of sling use between groups allows our analysis to focus on “mobilization” as defined by thetiming the first visit of supervised physical therapy. For nearly all measures, including post-operative rotator cuff healing, patient reported outcome measures, and post-operative medication use, early and delayed moblizationparadigms yield similar outcomes.

Early mobilization favors improved range of motion (Cuff et. al. 2012; Duzgun et. al.2014, Keener et. al. 2014; Mazzocca et al. 2017) and quality of life patient reported outcome measures (Mazzocca et al.) when compared to  patients who delayedmobilization, but these differences become negligible by 6 months post-operatively.

Delayed mobilizationuntil 4-8 weeks post-operatively is associated with higher rates of post-operative healing. However, these differences do not reach statistical significance in the 5 best available evidence studies which analyzed rotator cuff integrity (Cuff et. al. 2012 , DeRoo et. al.2015, Keener et al.2014, Koh et. al. 2014, Mazzocca et. al.2017).  Post-operative healing was analyzed by US and/ or MRI from 7 days (Mazzocca et. al. 2017) through up to 2 years post-operatively (Keener et. al. 2014, Koh et. al. 2014).

In summary, early (0-2 weeks) or delayed (4-8 weeks) mobilizationyields similar outcomes in rotator cuff healing, range of motion, and patient reported outcome scores.   Early mobilization tends to favor improved range of motion through the first 6 months post-operatively while delaying mobilization exercises is associated with higher rates of post-operative healing particularly for tears of larger size.

Risks and Harms of Implementing this Recommendation
Because the early and delayed mobilization protocols yield similar results there is no known harm from implementing this recommendation.

Future Research
This question centers on the timing of post-operative mobilization exercises, defined in the 6 studies reviewed here, as the initiation of supervised physical therapy.  Although easy to quantify, a physical therapy visit may not be the measure most indicative of stress on the healing repair.  Absolute load and cyclic loading have been identified as factors affecting suture durability in biomechanical studies. 

Counting the number of physical therapy visits assumes that the amount of load and the cycles across the tendon-suture-bone interface are consistent across rehabilitation protocols.  Perhaps it is not surprising that there are few differences between early and delayed rehabilitation protocols when the measure of dosing is a physical therapy visit. If researchers want to further elucidate the differential impacts of loading a rotator cuff repair either a more finite measure of dosing should be used (number of total cycles), the study period should be shorter (12 weeks), or the rehabilitation protocols need to be more disparate.  At minimum, future research should examine the dose and load of exercise (as measured by consistent attendance at supervised physical therapy visits and consistent completion of a home exercise program) over the course of post-operative care. Finally, , more patient centric outcome measures such as the WORC quality of life score (Mazzocca et. al.) should be routinely incorporated to determine the direct impact on the patient of differing rehabilitation protocols.
Corticosteroid Injections for Rotator Cuff Tears
Moderate evidence supports the use of a single injection of corticosteroids with local anesthetic for short-term improvement in both pain and function for patients with shoulder pain.
Moderate Evidence Moderate Evidence
One high quality study (Eyigor, C., 2010) compared corticosteroid injections with transcutaneous electrical nerve stimulator (TENS) treatment for the treatment of rotator cuff tendinitis. It showed an advantage in favor of injections with improvement in pain and functional scores for up to 12 weeks following the injection.

One high quality study (Rabini, A, 2012) compared corticosteroid injections with hyperthermia via localized microwave diathermy for rotator cuff tendinopathy with a follow up of 24 weeks. Both treatment groups showed equivalent improvement in functional scores but steroid injections showed better pain scores.

One high quality study (Penning, L. I. F., 2012) compared subacromial corticosteroid injections with hyaluronic acid injections or lidocaine (placebo injections in patients with subacromial impingement. There was no convincing benefit detected from hyaluronic acid injections compared with corticosteroid or placebo injections, whereas corticosteroid injections produced a better reduction in pain compared with placebo at 12 weeks but not at 26 weeks.

One high quality study (Alvarez, C. M., 2005) compared subacromial injection of corticosteroid injection to placebo (xylocaine) in chronic rotator cuff tendinosis. They were no more effective in improving the quality of life, range of motion, or impingement sign than xylocaine alone in patients with chronic rotator cuff tendinosis for all follow-up time intervals evaluated.

One high quality study (Kang, H., 2016) compared the efficacy of subacromial injection with sodium bicarbonate versus corticosteroid in patients with chronic subacromial bursitis: Both injections were equivalent in functional and pain scores for up to 4 weeks.

Despite the high quality of the above studies, the strength of the recommendation was downgraded to moderate due to variability of study findings.

Risks and Harms of Implementing this Recommendation
Corticosteroid injections in the setting of rotator cuff tears may be detrimental to the healing potential following cuff repair. Considering that rotator cuff diagnoses are clinical, a single corticosteroid injection may be given to confirm the presence of a symptomatic rotator cuff tear, but may adversely affect surgical outcomes.

Future Research
Further research is recommended to determine the role of corticosteroid injections in the various settings of rotator cuff pathology. Currently there is no high quality studies specifically addressing the role of corticosteroid injections in partial and / or full thickness cuff tears.
Hyaluronic Acid Injections for Rotator Cuff Tears
Limited evidence supports for the possible use of hyaluronic acid injections in the non-operative management of rotator cuff pathology with no tears.
Limited Evidence Limited Evidence
One high quality study (Penning, L. I. F., 2012) compared subacromial corticosteroid injections with hyaluronic acid injections or lidocaine (placebo) injections in patients with subacromial impingement. There was no convincing benefit detected from hyaluronic acid injections compared with corticosteroid or placebo injections for up to 26 weeks.

One moderate quality study (Moghtaderi, A. 2013) compared ultrasound guided subacromial sodium hyaluronate injection saline in patients with impingement syndrome without complete tear of rotator cuff at 12 weeks. Both injections showed improvement, but sodium hyaluronate showed better results.

One moderate quality study (Byun, S. D. 2011) sono-guided subacromial bursa injection of steroid injection followed by sodium hyaluronate injection once a week for 3 weeks with a sono-guided subacromial bursa steroid injection once a week for 3 weeks for patients with subacromial bursitis, partial or complete rotator cuff tear. The study concluded that Subacromial bursa injection of hyaluronate with steroid in patients with peri-articular shoulder disorders has additive effects on functional improvement.

One moderate quality study (Ozgen, M.; 2012) compared short- and long-term effect of intraarticular sodium hyaluronate injection in patients with supraspinatus tendinitis (ST) with conventional physiotherapy methods. Both groups received home exercise programs. The study concluded that physical therapy modalities and SH application had similar effects in short- and long term for painful ST.

One moderate quality study (Meloni, F 2008) examined the effect of ultrasound guided periarticular injection of hyaluronate into shoulders with supraspinatus tendinosis compared to saline injections. Both were done weekly for a total of 5 injections. At 12 months follow up, sodium hyaluronate had better clinical outcomes.

Despite the medium-high quality of the above studies, the strength of the recommendation was downgraded to limited due to variability of study findings.

Risks and Harms of Implementing this Recommendation
There are no known risks to hyaluronic acid injections that are specific to shoulders or the rotator cuff.

Future Research
Further research may be conducted to further define the role of hyaluronic acid injections in rotator cuff pathology.
Platelet Rich Plasma (PRP) Injection in Partial-Thickness Tears
Limited evidence does not support the routine use of platelet rich plasma for the treatment of cuff tendinopathy or partial tears.
Limited Evidence Limited Evidence

Three high quality studies (Nejati 2017, Kesikburun 2013, Rha 2013) provided conflicting evidence regarding the role of platelet rich plasma (PRP) in cuff tendonopathy or partial tears.

One high quality study (Nejati 2017) compared PRP to exercise therapy for the treatment of subacromial impingement.  Both PRP and exercise therapy showed improvement  up to 6 months but exercise was more effective.

One high quality study (Kesikburun 2013) compared PRP to placebo (saline) injection therapy for the treatment of rotator cuff tendonopathy or partial tears for up to one year. Both treatments shows improvement in QoL, Function and pain scores but were equivalent at all time points.

One high quality study (Rha 2013) compared PRP to dry needling for up to 6 months. Functional scores of the platelet-rich plasma injection were superior to those of dry needling.

Despite the high quality of the above studies, the strength of the recommendation was downgraded to limited due to variability of study findings.

Risks and Harms of Implementing this Recommendation
There are no known risks to PRP injections that are specific to shoulders or the rotator cuff.

Future Research
Further research may be conducted to further define the role of PRP injections in rotator cuff pathology. Future studies should standardize the type of PRP formulation utilized or at the very least measure the concentrations of key constituents.

 

High-Grade Partial Thickness Rotator Cuff Tears
Strong evidence supports the use of either conversion to full-thickness or transtendinous/in-situ repair in patients that failed conservative management with high-grade partial thickness rotator cuff tears.
Strong Evidence Strong Evidence
There were two high quality study (Kim Y-S et al. 2015, and Shin et al. 2012) and two moderate quality studies (Castagna et al., Franceschi et al.).  The remainder of published studies either had too few subjects (<20) or were low quality level IV studies.  Kim Y-S et al. in a level II study noted no difference in either clinical outcomes or re-tear rates comparing transtendinous versus tear completion in Ellman III partial thickness rotator cuff tears.  Bursal side cuff tears had a higher re-tear rate with either technique.  Shin et al. in a level II study noted similar outcomes for the two groups but noted a significantly faster recovery with tear completion.  Retears were higher in the tear completion group but did not reach statistical significance. Castagna et al. looked at a total of 74 patients randomized to transtendinous versus tear completion.  There were no significant differences between the two groups.  Franceschi et al. in a level II study felt that outcomes and re-tear rates were comparable between transtendinous repair and tear completion.

Risks and Harms of Implementing this Recommendation
None.

Future Research
Additional high quality level one studies with longer follow-up would be useful to establish if the results of these techniques hold up with time. Larger studies might also establish risk of retear with differing techniques.
Prognostic Factors (Age)
Strong evidence supports that older age is associated with higher failure rates and poorer patient reported outcomes after rotator cuff repair.
Strong Evidence Strong Evidence
Three high quality studies (Deniz 2014, Park 2015, Rashid 2017) demonstrated higher re-tear rates are associated with advanced age.    Four high quality studies (Chung 2012, Deniz 2014, Kim 2016, Robinson 2013) demonstrated worse patient reported outcomes in patients with older age.

Risks and Harms of Implementing this Recommendation
While older age is associated with higher failure rates and poorer patient reported outcomes, age alone should not be used as a contraindication for rotator cuff repair, as failure to heal is related to multiple features.  Older patients should be counseled that they would be at increased risk for failure and poorer outcomes than younger patients who undergo rotator cuff repair.

Future Research
Degenerative rotator cuff disease is a phenomenon of aging, yet there is great variability in this phenomenon.  Future research is needed to distinguish chronological age from physiologic age, and healing will likely improve when age related changes to the rotator cuff are better understood and manipulated.
Prognostic Factors (Higher BMI)
Moderate evidence supports that higher BMI is correlated with higher re-tear rates after rotator cuff repair surgery; however, strong evidence supports that there is no correlation between higher BMI and worse patient-reported outcomes following rotator cuff repair.
Moderate Evidence Moderate Evidence
One high quality study (Kim 2018) demonstrated that higher BMI was associated with higher re-tear rates after rotator cuff repair.

Four high quality studies demonstrated either no difference in patient reported outcomes for patients with high BMI (Namdari 2010, Potter 2015, Wylie 2018), or improved patient reported outcomes in patients with higher BMI (Chalmers 2018) after rotator cuff repair, in part related to a lower starting ASES scores and pain VAS in patients with higher BMI.

Risks and Harms of Implementing this Recommendation
Patients with higher BMI may be at higher risk for perioperative complications, yet the literature supports that these patients should be treated surgically if indicated, as they can expect improved patient reported outcomes.

Future Research
Patients with higher BMI generally start with lower scores on patient reported outcome measures.  Future research should investigate if this starting point changes with weight loss, and how this affects the improvement in patient reported outcomes after surgery.
Prognostic Factors (Worker's Compensation)
Strong evidence supports the presence of a worker’s compensation claim is associated with poorer patient reported outcomes after rotator cuff repair.
Strong Evidence Strong Evidence
Two high quality studies (Millett 2017, Namdari 2010) demonstrate poorer patient reported outcomes after rotator cuff repair in patients who have a worker’s compensation claim.

Risks and Harms of Implementing this Recommendation
There are no undue risks or harms when performing rotator cuff repair on patient who have pending worker’s compensation claims, however patients should be counseled that patient reported outcomes are better when no claim is present.

Future Research
It would be important to know what features (job satisfaction, manual labor job, resiliency, etc.) might predict poorer patient reported outcomes after rotator cuff repair in the population of worker’s compensation patients.
 
Prognostic Factors (Comorbidities)
Moderate evidence supports the association of poorer patient reported outcomes in patient with more comorbidities
Moderate Evidence Moderate Evidence
Two high quality studies (Namdari 2010, Tashjian 2006) correlated the number of comorbidities to worse patient reported outcomes in patients who underwent rotator cuff repair surgery.

Risks and Harms of Implementing this Recommendation
While perioperative complications could be increased when performing rotator cuff repair surgery on patients with multiple comorbidities, this should not be used as a contraindication for surgery.  Patients should be counseled that they may be at increased risk for poorer outcomes compared to patients who are healthier.

Future Research
While the number of comorbidities does influence patient reported outcomes after rotator cuff repair surgery, it would be important to understand the risk stratification of specific comorbidities to accurately make recommendations about the expected outcomes.
Prognostic Factors (Diabetes)
Moderate evidence suggests that patients with diabetes will have higher re-tear rates and poorer quality of life and patient reported outcome scores after rotator cuff repair.
Moderate Evidence Moderate Evidence
One high quality study (Kim 2018) demonstrated higher rotator cuff repair re-tears in patients with diabetes.  One high quality study (Chung 2012) demonstrated poorer patient reported outcome scores using the HRQOL physical health-related quality of life in patients with diabetes.

There are no undue risks or harms when performing rotator cuff repair on patient who have diabetes, other than perioperative complications related to having diabetes (e.g. adhesive capsulitis).  Patients should be counseled that patient reported outcomes are poorer compared to patients without diabetes.

Future Research
Future research should determine if adequate control of diabetes will improve patient reported outcomes and improve healing after rotator cuff repair.
Prognostic Factors (Patient Expectations)
Moderate evidence correlates higher preoperative patient expectations for surgery with higher patient reported outcomes after rotator cuff repair.
Moderate Evidence Moderate Evidence
One study (Henn 2007) correlated the score from the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS) questionnaire-used to measure patient expectations- to SST, VAS, SF-36, SST, DASH and found that greater preoperative expectations correlated with better postoperative patient reported outcome scores.

Risks and Harms of Implementing this Recommendation
There are no undue risks or harms when performing rotator cuff repair on patients different expectations after surgery, however patient reported outcomes may be lower in patients with lower expectations and patients should be advised of this finding.

Future Research
There is currently very little research on optimal ways to evaluate and influence patient expectation.
Biological Augmentation with Platelet Derived Products
Strong evidence does not support biological augmentation of rotator cuff repair with platelet-derived products on improving patient reported outcomes; however, limited evidence supports the use of liquid platelet rich plasma (PRP) in the context of decreasing re-tear rates.
Strong Evidence Strong Evidence
Several high strength studies confirm that the addition of liquid platelet-rich plasma or platelet-rich fibrin does not significantly change patient-reported outcomes.

Seven high quality studies (Jo, C.H. 2015; Malavolta, E.A. 2014; Pandey, V. 2016; Randelli, P., 2011; Wang, A. 2015; Zhang, Z. 2016; Flury 2016)  that investigated the effect of liquid platelet rich plasma (PRP) on post-operative full thickness re-tear rates.  A pooled analysis of randomized trials demonstrated a lower relative risk of full thickness re-tear [RR=0.43 (95% CI 0.26 – 0.69)] when patients treated PRP were compared with controls.  While there was minimal statistical heterogeneity (I2=3.6%) in this analysis, there was a significant amount of clinical variability in the size of the tears, the type of PRP kit that was utilized, PRP application techniques, and fixation constructs.  Given that an uncontrolled analysis was conducted (i.e. not enough studies for a meta-regression), the results should be interpreted with caution.  With respect to platelet rich fibrin, there is insufficient evidence to make a recommendation for or against its utilization in reducing post-operative rotator cuff re-tear rates. Due to limited numbers in the pooled analysis, subgroup analyses for rotator cuff tear size could not be performed.

Risks and Harms of Implementing this Recommendation
There are no known harms associated with the use of PRP.

Future Research
Future studies should standardize the type of PRP formulation utilized or at the very least measure the concentrations of key constituents.  Furthermore, larger studies will allow for controlled statistical analyses that consider the effect of confounders such as fixation constructs, marrow venting, size of tears, etc. Consistency in the definition of rotator cuff re-tear is also encouraged.
Single-Row vs Double-Row Repair
Strong evidence does not support double row rotator cuff repair constructs on improving patient-reported outcomes compared to single row vertical mattress repair constructs.
Strong Evidence Strong Evidence
Nine high quality randomized controlled trials (RCTs) comparing single row versus double row constructs for full thickness rotator cuff tears reported significant improvement in all patient reported outcomes (PROs) at final follow-up; however, there were no clinically meaningful difference in PROs between the two repair groups (Aydin 2010, Barber 2016, Burks, 2009, Franceschi 2016, Franceschi 2007, Koh 2011, Lapner 2012, Ma 2012, Carbonel 2012). Two high quality RCTs reported significant improvement in PROs (UCLA scores, ASES scores, or strength testing) favoring double row repair in patients with >3cm full thickness rotator cuff tears (Ma 2012, Carbonel 2012) Aydin et al reported no difference in the Constant scores or complication rates between the two groups of single row (N=34) and double row (N=34) repair at final follow-up.  Barber et al also reported no difference in all PROs between single row (N=20) compared to double row (N=20) repair for full thickness cuff tears less than 3cm augmented with platelet-rich plasma fibrin membrane.  The failure rate at final follow-up was also similar between both groups, 3 out of 20 (15%) in each group.  Furthermore, Burks et al, Franceschi et al, , Koh et al, and Lapner et al also found no clinically meaningful difference in the PROs between single row and double row repair for full thickness rotator cuff tears at final follow-up.  Ma et al also reported similar UCLA and ASES scores at final follow-up comparing single to double row repair. However, in the subset of patients with >3cm full thickness tears, the authors reported significantly better shoulder strength in abduction and external rotation with double row repair at final follow-up.  In the largest RCT comparing the outcome of single row versus double row repair, Carbonel et al reported similar PROs in patients with 1cm to 3cm tears. However, in patients with >3cm tears, double row repair showed superior results in both UCLA and ASES scores compared to single row repair.

Risks and Harms of Implementing this Recommendation
There is no harm to patients by implementing this recommendation for small to medium size rotator cuff tears.  However, in patients with larger rotator cuff tears (>3cm), single row vertical mattress repair may result in inferior PROs and higher failure rates compared to double row repair constructs.

Future Research
Future research needs to be performed to evaluate for both PROs and failure rates on imaging and reoperation rates between single row compared to double row repair for larger full thickness rotator cuff tears >3cm in size.
Single-Row vs Double-Row Repair Re-Tears
Strong evidence supports lower re-tear rates after double row repair compared to single row vertical mattress repair when evaluating for both partial and full thickness retears after primary repair; however, when evaluating the data for only full thickness retears, limited evidence does not support lower re-tear rates after double row primary repair.
Strong Evidence Strong Evidence
Eight high quality randomized controlled trials (RCTs) utilized magnetic resonance imaging (MRI) reported the re-tear rates after single row versus double row repair in patients with full thickness rotator cuff tears. (Barber 2016, Burks 2009, Franceschi 2016, Franceschi 2007, Koh 2011, Lapner 2012, Ma 2012, Carbonel 2012). 

When the re-tear rates include both partial and full thickness tears, a meta-analysis of the pooled data from these eight RCTs identified the relative risk (RR = 0.58 (0.43-0.78)) of re-tear is significantly lower after double row repair compared to single row repair for full thickness rotator cuff tears.  Thus, there is strong evidence that supports lower re-tear rates (partial and full thickness) after double row repair compared to single row vertical mattress repair for full thickness rotator cuff tears.

However, when re-tears are defined as full thickness only, the relative risk (RR = 0.71 (0.45-1.11)) is 0.71 with a wider confidence interval (0.45 – 1.11) which indicates limited evidence to support lower risk of re-tear (Full thickness) after double row compared to single row repairs.

Risks and Harms of Implementing this Recommendation
There is no harm to patients by implementing this recommendation.  However, partial and full thickness re-tear rates may be higher after single vertical mattress repair compared to double row in patients with full thickness rotator cuff tears.  The clinical significance is unknown.

Future Research
Future research should be performed to evaluate for failure rates on imaging and reoperation rates between single row compared to double row repair for full thickness rotator cuff tears.  Research also needs to be done to better identify the clinical significance of a partial thickness re-tear after arthroscopic rotator cuff repair.
Marrow Stimulation
Limited evidence suggests that marrow stimulation at the time of rotator cuff repair does not improve patient-reported outcomes; however, this technique may decrease re-tear rates in patients with larger tear sizes.
Limited Evidence Limited Evidence
Three low to high quality studies (Milano G. 2010, Osti, L. 2010, Taniguchi, N. 2015) demonstrated that marrow stimulation (MS) does not have an effect on patient reported outcomes such as the constant score.  One low quality study (Taniguchi) did demonstrate a decrease in re-tear rates. A high quality study by Milano demonstrated decreased re-tear rates in larger tears.

Risks and Harms of Implementing this Recommendation
The risk of complications with MS is low.  If several microfracture holes are made in the footprint that are too close together there is the theoretical potential of comprising the fixation strength of suture anchors.

Future Research
Future studies should be large enough such that the statistical analyses will allow for consideration of confounders such as fixation constructs, size of tears, etc.. Consistency in the definition of a rotator cuff re-tear is also encouraged.
Dermal Allografts
Limited evidence supports the use of dermal allografts to augment the repair of large and massive rotator cuff tears to improve patient reported outcomes.
Limited Evidence Limited Evidence

There was one moderate strength study (Barber et al. 2012) and one low strength studies (Gilot et al. 2015).  The remainder of published studies either had too few subjects (<20) or involved interpostion rather than augmentation of rotator cuff repair.  Barber et al., in a moderate quality study, involved a comparison of two-tendon three-centimeter tears with or without an acellular human dermal matrix allograft augmentation.  Both Constant scores and re-tear rates were significantly improved with use of the allograft augmentation, with no adverse events related to the allograft.  Gilot et al. in a low quality study of 20 acellular dermal matrix augmented repairs versus 15 unaugmented repairs, noted a significantly decreased rate of retears and significantly improved outcome scores with augmented repairs. There were no graft related complications in the study of Gilot.

Risks and Harms of Implementing this Recommendation
The use of dermal allografts increases operating time and thus may increase infection rates and other surgical time-related complications.  Use of dermal allografts will also substantially increase the cost of rotator cuff surgery.

Future Research
Given the risks and costs involved with these devices, high quality studies would be useful to definitively establish the benefits of these device.
 

Xenografts
Limited evidence does not support the use of xenografts to augment the repair of large and massive rotator cuff tears.
Limited Evidence Limited Evidence
One high quality study (Bryant, D. 2016), one moderate quality study (Iannotti, J. 2006), and three low quality studies (Flury, M. 2018 , Walton, J. 2007, Ciampi, P. 2014 ) addressed xenografts as an ancillary surgical technique.  The remainder of published studies either had too few subjects (<20) or involved interposition rather than augmentation of rotator cuff repair.

In a high quality study, Bryant et al. 2016 compared a porcine xenograft patch to no augmentation in the repair of moderate and large size rotator cuff tears.  While they demonstrated non-inferiority for the porcine xenograft, no significant difference was found between the two groups for either re-tear or patient reported outcomes (PROs), although there was a trend to better PROs for the xenografts.

In a moderate quality study, Iannotti et al. 2006 compared a porcine xenograft augmentation in the repair of two tendon tears.  While not statistically significant (p=0.08), the study trended towards worse outcomes in the xenograft augmented group.  Three of 15 developed wound problems in the xenograft group.  The authors did “not recommend using porcine small intestine submucosa to augment repairs of massive chronic rotator cuff tears done with the surgical and postoperative procedures described in this study.”

In a low quality study, Flury et al. 2018 compared the outcome of porcine xenograft augmentation in patients age>60 using a matched-pair comparative trial design.  No difference in outcomes was noted, with a trend (p=0.343) towards more local complications in the xenograft group.  In a different low quality study, Walton et al. 2007 also evaluated a porcine xenograft.  This study noted “no recognizable benefit” with the porcine xenograft, and 4/10 had a severe post-operative reaction requiring further surgical treatment in the xenograft group.  In a low quality cohort study, Ciampi et al. evaluated the results of augmentation with a bovine xenograft augmentation versus no graft in two arms of the study, with a third arm being synthetic patch augmentation.  No difference was noted in strength, elevation, or re-tear rates with xenograft augmentation, compared to no augmentation of the repairs.  No local inflammation was noted in the xenograft group.

Risks and Harms of Implementing this Recommendation
There are no known harms associated with implementing this recommendation.  Multiple other option for augmentation of rotator cuff repairs exist besides xenograft.

Future Research
While the evidence available to recommend for or against xenograft augmentation is mixed, the absence of clear benefit associated with these grafts, and the increased incidence of post-operative reaction coupled with the absence of reports of these reactions with allograft augment would seem to indicate that further research is not warranted at this time on xenografts in their current form.
Open vs Arthroscopic Repairs
Strong evidence supports no difference in long-term (> 1 year) patient-reported outcomes or cuff healing rates between open and arthroscopic repairs; however, arthroscopic-only technique is associated with better short-term improvement in post operative recovery of motion and decreased visual analog scale (VAS) scores.
Strong Evidence Strong Evidence
There were four high quality studies (Carr 2017, Liu, J. 2017, Mohtadi, N. 2008; Van der Zwaal, P. 2013) comparing the outcome of arthroscopic and either open or mini-open repair and two moderate quality studies comparing perioperative pain and morbidity between arthroscopic and open rotator cuff repair.  None of these six studies reported any significant difference in the outcome of any of the three techniques. Multiple other comparative stuides of lower quality exist regarding this topic, some with differing outcomes, but only the best available evidence was considered in the development of this recommendation. 

In a prospective, randomized high quality study, Carr et al. (2017) evaluated the outcome of 273 patients randomized to either open/mini-open, or all-arthroscopic repair.  There was no difference in outcome scores, with a 40% healing rate in both groups.  This study extended the preliminary results of Carr et al. study reported in 2014.

In a high quality prospective randomized study of 100 patients, Liu et al. 2017 showed no difference in outcome between all-arthroscopic and mini-open repairs for either patient reported outcomes, retear rates, or occurrence of adhesive capsulitis at one year.
Mohtadi et al. 2008 published a high quality study comparing open to mini-open repair showed no difference in PROs with either technique at average follow-up of 28 months.  No post-operative imaging was performed.

Van der Zwaal et al. 2013 presented a high quality study comparing all-arthroscopic to mini-open repair at one year.  Final PROs, retear rates, and presence of associated adhesive capsulitis were similar between both groups.

In evaluating the literature which forms the basis for this recommendation, two high-quality studies (Liu et al. 2017 and Van der Zwaal et al. 2013) showed faster short-term recovery with all-arthroscopic repair.  Liu et al. 2017 showed significant difference in both range of motion and VAS scores as well as superior scores on both the DASH and Constant PRJOs up to one-month postoperatively.  Liu concluded that the all-arthroscopic procedure has better recovery at short-term follow-ups.  Similarly, Van der Zwaal et al. noted improved range of motion, VAS, and DASH scores at six weeks comparing all-arthroscopic to mini-open repair.  They felt that “Patients do attain the benefits of treatment somewhat sooner (6 weeks) with the arthroscopic procedure.”

Risks and Harms of Implementing this Recommendation
There are no risks associated with implementing this recommendation.

Future Research
Given the conflicting information available regarding improvements in post-operative pain and early recovery with all-arthroscopic repair, further studies are needed in this area to establish benefits of this procedure.
 
Postoperative Pain Management
Moderate strength evidence supports the use of multimodal programs or non-opioid individual modalities to provide added benefit for postoperative pain management following rotator cuff repair.
Moderate Evidence Moderate Evidence
A number of articles, of both high and moderate quality (Bain, G. I. 2001, Banerjee, S. S. 2008, Bang, S. R. 2010, Behr, A. 2012, Borgeat, A. 2010, Ciccone, Ii W. J. 2008, Clendenen, S. R. 2010, Coghlan, Ja 2009, Culebras, X 2001, Desmet, M. 2013, Desmet, M. 2015, Faria-Silva, R. 2016, Fredrickson, M. J. 2011, Hadzic, A. 2005, Hartrick, Ct 2012, Hoe-Hansen, C. 1999, Kim, Jy 2016, Klein, Sm 2000, Ko, S. H. 2017, Kraeutler, M. J. 2015, Lee, Ar 2012, Lee, Hj 2015, Lee, J. J. 2017, Lee, J-H 2011, Lee, Jj 2014, Lee, Jj 2015, Lin, Y. H. 2015, Liu, X. N. 2017, Mahure, S. A. 2017, Malik, T. 2016, Merivirta, R. 2012, Oh, J. H. 2009, Osti, L. 2015, Park, J. Y. 2016, Schwartzberg, Rs 2013, Shin, H. J. 2016, Sun, Z. 2018, Takada, M. 2009, Thackeray, E. M. 2013, Watanabe, K. 2016, Yamakado, K. 2014, Yun, M. J. 2012), addressed a variety of individual and multimodal pain management modalities. Based on this literature,  it is clear that any one of a variety of pain management non-opioid medications or modalities has a positive impact on patient pain control in the post-operative period. It should be noted that most of the literature validated a singular approach against a singular control group and did not perform a direct comparison against all other options, nor were indirect comparisons of the literature review findings using network meta-analysis statistically feasible. . This led to the inability to rank-order pain management modalities in a “most effective” to “least effective” manner. Because of this, the guideline development group framed the pain management recommendations as a more general list of pain management modalities, both singular and multimodal, which exhibited comparative efficacy, as compared to their within-study comparisons.

Defining multimodal therapy as using multiple but different modalities of pain management therapies simultaneously in the same post-operative period, the study group was able to arrive at the second multimodal pain management recommendation (recommendation B). The evidence assessing multimodal pain management supported the use of multimodal pain management treatment compared to a single modal approach. In particular, four high quality studies (Jo, 2014; Perdreau, 2015; Syed, 2018; Han, 2013) support the concept of multimodal therapy although the specifics of which mix of options is the most optimal requires further research.

Risks and Harms of Implementing this Recommendation
While the study group’s conclusion that there are various successful options of both singular and multimodal post-operative pain management has moderate strength of evidence, the analysis did not include a risk benefit comparison of options.  Each individual medication or modality carries its own inherent risks and benefits which should be taken into account by the health care provider prescribing the intervention.

Future Research
The analysis of this question has exposed the need for future research particular into the pros and cons of each medication, modality, and multimodal program as they are compared to each other.  The collective data and indirect comparisons from the high quality articles cited in this recommendation could be used to perform a network meta-analysis, providing valuable information to best guide future management.
Supervised Exercise vs Unsupervised Exercise
In the absence of reliable evidence, it is the opinion of the work group that supervised physical therapy is more appropriate than unsupervised home exercise for some patients following rotator cuff repair.
Consensus Consensus
Multiple Steroid Injections for Rotator Cuff Tears
In the absence of reliable evidence, it is the opinion of the work group that multiple steroid injections may compromise the integrity of the rotator cuff, which may affect attempts at subsequent repair.
Consensus Consensus
Platelet Rich Plasma (PRP) Injection in Full-Thickness Tears
In the absence of reliable evidence, it is the consensus of the work group that we do not recommend the routine use of PRP in the non-operative management of full-thickness rotator cuff tears.
Consensus Consensus
Partial Rotator Cuff Tear
In the absence of reliable evidence, the work group is unable to define a preference for the choice of debridement versus repair of high-grade partial-thickness cuff tears that have failed physical therapy, however repair of high grade partial tears could improve outcomes.
Consensus Consensus
Rationale
The limited publications comparing debridement to partial tear repair of the rotator cuff all are excluded under the exclusion criteria for the Guidelines.  Only two retrospective, comparative studies exist, both of which are case series studies that have non-consecutive enrollment of patients and so were excluded.   Weber SC (Weber, 1999) published a low quality study comparing an early series of debrided patients outcomes to a later series of repaired partial rotator cuff tears and had superior clinical outcomes and lower reoperation rates with partial tear repair.  Ogilvie-Harris et al. (Ogilvie-Harris,1993) evaluated a similar non-consecutive group. The open repair group scored better for function, strength and overall score, but patient satisfaction was similar in the two groups. They recommend repair for active patients, and debridement for low activity patients.

Risks and Harms of Implementing this Recommendation
While, given the level of evidence, overtreatment of partial rotator cuff tears may occur, what data is available suggests that only minimal harm would be associated with implementing this recommendation.

Future Research
High strength comparative studies between debridement and partial tear repair may further clarify the utility of these two techniques in managing partial rotator cuff tears.
 
Unrepairable Tears Without Arthropathy (Non-Reverse Arthroplasty)
In the absence of reliable evidence, it is the opinion of the work group that physical therapy, biceps tenotomy/tenodesis, partial repair, tendon transfer, superior capsular reconstruction, arthroscopic debridement, or graft augmentation (non-porcine) can improve patient reported outcomes.
Consensus Consensus
Massive, Unrepairable Rotator Cuff Tear (Reverse Arthroplasty)
In the absence of reliable evidence, it is the opinion of the work group that in patients with massive, unrepairable tears and significant functional loss who have failed other treatments, reverse arthroplasty can improve patient reported outcomes.
Consensus Consensus
Unrepairable Tears with Arthropathy
In the absence of reliable evidence, it is the opinion of the workgroup that after failure of conservative treatment, reverse shoulder arthroplasty for unrepairable tears with glenohumeral joint arthritis can improve patient reported outcomes.
Consensus Consensus

ACKNOWLEDGMENTS

Guideline Work Group:
Stephen Weber, MD, Co-Chair
Jaskarndip Chahal, MD, Co-Chair
Shafic A. Sraj, MD
Jason M. Matuszak, MD
Amee L. Seitz, PhD, PT
Lori A. Michener, PhD, PT, ATC
Mark R. Hutchinson, MD
Michael A. Shaffer, PT, ATC, OCS
Xinning Li, MD
Michael M. Albrecht, MD
Christopher C. Schmidt, MD
John Kuhn, MD, MS
Leesa Galatz, MD

Oversight Chair:
Gregory A. Brown, MD, PhD, Chair

AAOS Staff:
William O. Shaffer, MD, AAOS Medical Director
Jayson Murray, MA, Director, Clinical Quality & Value
Ryan Pezold, MA, Manager, Clinical Quality & Value
Kyle Mullen, MPH, Manager, Clinical Quality & Value
Mary DeMars, Coordinator, Clinical Quality & Value
Mukarram Mohiuddin, MPH, Lead Research Analyst, Clinical Quality & Value
Syed Hussain, MS, Research Analyst, Clinical Quality & Value
Peter Shores, MPH, Statistician, Clinical Quality & Value
Kaitlyn Sevarino, MBA, CAE, Senior Manager,Clinical Quality & Value
Anne Woznica, MLIS, AHIP, Medical Research Librarian, Clinical Quality and Value

AAOS Clinical Practice Guidelines Section Leader
Gregory Brown, MD, PhD

AAOS Committee on Evidence-Based Quality and Value Chair
Kevin Shea, MD

AAOS Council on Research and Quality Chair
Robert H. Quinn, MD

LEARN MORE ABOUT AAOS

The Future of OrthoGuidelines

FIND OUT MORE

The OrthoGuidelines Process