Limb Salvage or Early Amputation

The Physician team should evaluate overall burden of injury and patient physiology when considering if initial limb salvage is advisable.

RATIONALE:

There is limited evidence that the poly-trauma patient with combined lower extremity injuries require limb salvage attempts. In the study from Webster (2018), in a military population of high ISS greater than 26 and bilateral and unilateral amputation, patients with pelvic fractures had increased mortality. Additionally, those with bilateral lower extremity amputations had a higher risk of death.

In Allami (2017), in veterans with ankle-foot injuries, having additional injuries was a determinant of poorer mental health and poorer PCS scores. In the study from Laferrier (2010) in a population of military polytrauma patients, an increasing number of combat injuries (including bilateral limb loss, traumatic brain injury) is associated with higher odds of wheelchair use. Laferrier also found that in patients with bilateral lower-limb loss compared to those with unilateral limb loss, there was also a higher odds of wheelchair use. In the study by Hutchison (2014) in subjects with military related amputees, having multiple amputations was associated with an increased odds of PE and VTE. Additionally, in the study by Bennett (2018) in a military population with injuries to the foot and ankle, having coexisting talar and calcaneal fractures was found to be associated with lower AAOS F&A scores but the same was not seen for fractures of the mid-foot.

BENEFITS & HARMS:

In the acute setting, standard ATLS trauma resuscitation, and operative or non-operative management of the trauma patient injuries is paramount. The patient’s injuries are triaged based on addressing life-threating injuries (providing a stable airway, oxygenation) and stopping bleeding. Initial “Damage Control” trauma techniques are deployed (Damage Control Trauma Surgery and Damage Control Resuscitation). Damage control trauma and orthopedic surgery in the setting of a lower extremity injury may require re-establishing blood flow to the extremity, which can be a temporary vascular shunt, and external fixation.

IMPORTANT/PRIORITY OUTCOMES:

The priority at this point is survival of the patient.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

The cost of survival is high. The cost of a survivor with an amputation is higher.

ACCEPTABILITY:

High

FEASIBILITY:

High

FUTURE RESEARCH:
This injury pattern is not amenable to randomized control study as it would be considered unethical to attempt limb salvage in a patient who is dying from another injury.

 

In the absence of reliable evidence, the workgroup suggests the physician team should prioritize patient survival in the limb reconstruction vs. amputation decision. Limb specific damage control (i.e. temporizing) measures or immediate amputation should be considered when further attempts at definitive salvage will increase risk of mortality.

RATIONALE:

There is limited evidence that the poly-trauma patient with combined lower extremity injuries require limb salvage attempts. In the study from Webster (2018), in a military population of high ISS greater than 26 and bilateral and unilateral amputation, patients with pelvic fractures had increased mortality. Additionally, those with bilateral lower extremity amputations had a higher risk of death.

In Allami (2017), in veterans with ankle-foot injuries, having additional injuries was a determinant of poorer mental health and poorer PCS scores. In the study from Laferrier (2010) in a population of military polytrauma patients, an increasing number of combat injuries (including bilateral limb loss, traumatic brain injury) is associated with higher odds of wheelchair use. Laferrier also found that in patients with bilateral lower-limb loss compared to those with unilateral limb loss, there was also a higher odds of wheelchair use. In the study by Hutchison (2014) in subjects with military related amputees, having multiple amputations was associated with an increased odds of PE and VTE. Additionally, in the study by Bennett (2018) in a military population with injuries to the foot and ankle, having coexisting talar and calcaneal fractures was found to be associated with lower AAOS F&A scores but the same was not seen for fractures of the mid-foot.

BENEFITS & HARMS:

In the acute setting, standard ATLS trauma resuscitation, and operative or non-operative management of the trauma patient injuries is paramount. The patient’s injuries are triaged based on addressing life-threating injuries (providing a stable airway, oxygenation) and stopping bleeding. Initial “Damage Control” trauma techniques are deployed (Damage Control Trauma Surgery and Damage Control Resuscitation). Damage control trauma and orthopedic surgery in the setting of a lower extremity injury may require re-establishing blood flow to the extremity, which can be a temporary vascular shunt, and external fixation.

IMPORTANT/PRIORITY OUTCOMES:

The priority at this point is survival of the patient.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

The cost of survival is high. The cost of a survivor with an amputation is higher.

ACCEPTABILITY:

High

FEASIBILITY:

High

FUTURE RESEARCH:

This injury pattern is not amenable to randomized control study as it would be considered unethical to attempt limb salvage in a patient who is dying from another injury.

 

*Strength of Recommendation Upgraded. Evidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. Also requires no or only minor concerns addressed in the EtD framework.

Physicians should consider the cumulative injury burden (soft tissue, vascular, nerve, bone, joint) of the limb when counseling patients on anticipated outcomes of and making recommendations on when to pursue limb salvage or amputation treatment.

RATIONALE:

There is limited evidence that the poly-trauma patient with combined lower extremity injuries require limb salvage attempts. In the study from Webster (2018), in a military population of high ISS greater than 26 and bilateral and unilateral amputation, patients with pelvic fractures had increased mortality. Additionally, those with bilateral lower extremity amputations had a higher risk of death.

In Allami (2017), in veterans with ankle-foot injuries, having additional injuries was a determinant of poorer mental health and poorer PCS scores. In the study from Laferrier (2010) in a population of military polytrauma patients, an increasing number of combat injuries (including bilateral limb loss, traumatic brain injury) is associated with higher odds of wheelchair use. Laferrier also found that in patients with bilateral lower-limb loss compared to those with unilateral limb loss, there was also a higher odds of wheelchair use. In the study by Hutchison (2014) in subjects with military related amputees, having multiple amputations was associated with an increased odds of PE and VTE. Additionally, in the study by Bennett (2018) in a military population with injuries to the foot and ankle, having coexisting talar and calcaneal fractures was found to be associated with lower AAOS F&A scores but the same was not seen for fractures of the mid-foot.

BENEFITS & HARMS:

In the acute setting, standard ATLS trauma resuscitation, and operative or non-operative management of the trauma patient injuries is paramount. The patient’s injuries are triaged based on addressing life-threating injuries (providing a stable airway, oxygenation) and stopping bleeding. Initial “Damage Control” trauma techniques are deployed (Damage Control Trauma Surgery and Damage Control Resuscitation). Damage control trauma and orthopedic surgery in the setting of a lower extremity injury may require re-establishing blood flow to the extremity, which can be a temporary vascular shunt, and external fixation.

IMPORTANT/PRIORITY OUTCOMES:

The priority at this point is survival of the patient.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

The cost of survival is high. The cost of a survivor with an amputation is higher.

ACCEPTABILITY:

High

FEASIBILITY:

High

FUTURE RESEARCH:

This injury pattern is not amenable to randomized control study as it would be considered unethical to attempt limb salvage in a patient who is dying from another injury.

Clinicians should screen all patients with high energy lower extremity trauma for psychosocial risk factors (e.g. depression, PTSD, anxiety, low self-efficacy, poor social support) affecting patient outcomes.

RATIONALE:

STRENGTH OF EVIDENCE: Moderate

O’toole (JBJS-AM; 2008) determined that the presence of anxiety or depression at 2 years after injury decreased patient satisfaction. MacKenzie (JBJSn-AM; 2005) found that patients with low self-efficacy had worse Sickness Impact Profile (SIP) scores. Melcer (JOT; 2013) showed that lower extremity trauma amputees had greater odds of mood disorders. Furthermore, PTSD risk was lower in amputees versus non-amputees. Bosse (N Engl J Med; 2002) concluded that amputees and non-amputees had higher SIP scores if they had poor self-efficacy and a poor social support network.

BENEFITS & HARMS:

Screening and treatment of psychosocial risk factors can increase patient satisfaction after amputation or limb salvage. Failure to address these risk factors have been shown to result in poor SIP scores, functional outcome, and patient satisfaction.

OUTCOME IMPORTANCE:

Identification and proper referral for psychosocial risk factors can help improve outcomes in all lower extremity trauma patients regardless of whether they receive amputation or limb salvage.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

Bhatnagar (J Rehabil Res Dev; 2015) demonstrated presence of PTSD resulted in higher prosthetic costs as well as cost associated with psychiatric treatment in amputees.

ACCEPTABILITY:
This recommendation is acceptable to all civilian and military lower extremity trauma patients undergoing amputation or limb salvage

FEASIBILITY:

This recommendation is feasible in trauma centers with proper referral services. The application of these services to provide psychosocial support will not affect surgical decision making and operative treatment.

FUTURE RESEARCH:

Current literature has shown that negative psychosocial factors results in poorer outcomes and satisfaction in both amputation and limb salvage. Long term studies are necessary to determine which factors are most important to address and what specific interventions are most effective.

 

* Strength of recommendation upgraded. Evidence from two or more “High” quality studies with consistent findings for recommending for or against the intervention. Also requires no reasons to downgrade from the EtD framework.
 

Clinicians should recommend patients with high energy lower extremity trauma injuries participate in a rehabilitation program (e.g. PT, OT, behavioral health) to improve psychological and functional outcomes.

RATIONALE:

Available evidence demonstrates the importance of psychosocial factors (e.g. anxiety, depression, Self-efficacy) on outcomes (O’Toole 2008, MacKenzie 2005) and indicates improvement through structured behavioral health intervention could improve outcomes. Further, improved psychosocial adjustment is associated with greater physical mobility. (Wen 2018)

Available evidence suggests a beneficial effect of physical therapy after severe high energy lower-extremity trauma. Individuals whose legs were salvaged after limb-threatening trauma to the lower limb, and had an unmet need for physical therapist directed care as determined by a physical therapist, have decreased odds of improvement in multiple domains of care as compared to patients whose needs were met (Castillo 2008).

In military service members, a structured clinical pathway including multi-disciplinary rehabilitative care (e.g. PT, OT, behavioral health) and a custom carbon fiber dynamic orthosis yielded significant improvements in physical mobility, patient reported outcomes and return to work (duty) following limb trauma. (Blair 2014, Potter 2018, Hsu 2017)

BENEFITS & HARMS:

The benefits of participation in a structured rehabilitation program (e.g. PT, OT, behavioral health) following high energy lower extremity traumatic injury are improved psychological and functional outcomes. Physical or psychological risks associated with receiving care from a qualified provider are limited. Participation in a structured rehabilitation program requires both transportation and dedicated time. Risks associated with an inability to access rehabilitative care include decreased functional and psychological outcomes.

IMPORTANT/PRIORITY OUTCOMES:

Priority outcomes include pain, the ability to complete essential activities of daily living, psychosocial state, the ability to return to full employment and the ability to participate in activities in the community.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

The financial cost and resource utilization associated with participation in therapist driven structured rehabilitative programs are outweighed by benefits in improved physical mobility, function, participation and psychosocial state. Logistical concerns and costs for individuals with limited resources are a primary consideration.

ACCEPTABILITY:

High

FEASIBILITY:

Moderate (Dependent on payor status, policy and patient resources)

FUTURE RESEARCH:

Additional studies examining the specific association between the type (e.g. PT, OT, behavioral health interventions) and volume of care (number and duration) and resulting outcomes are needed. These data would help optimize the care pathway following traumatic limb injury, particularly in the context of multi-system or multi-limb injury, community reintegration/participation and training to use prosthetic and/or orthotic devices.

 

Additional Rationale References:
1. Hsu, J.R., Owens, J.G., DeSanto, J., et. al. Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries: The PRIORITI-MTF Study. J Orthop Trauma 2017; 31:S56-S62.
2. Potter, B.K., Sheu, R.G., Stinner, D., et. al. Multisite Evaluation of a Custom Energy-Storing Carbon Fiber Orthosis for Patients with Residual Disability After Lower-Limb Trauma. J Bone Joint Surg Am. 2018; 100(20): 1781-1789.

The evidence suggests plantar sensation or an observed nerve transection is not a factor in the decision for limb salvage vs. amputation.

RATIONALE:

The evidence suggests that plantar sensation or an observed tibial nerve transection is not an absolute, major, or unique factor for early amputation. In 2005, Bosse et al. (as part of the LEAP study) identified 55 patients with an insensate extremity (lack of plantar sensation) after lower extremity trauma. They found the presence of an insensate foot at the time of presentation did not adversely affect limb salvage at both 12- and 24-months post injury. More recently Bennett et al. in 2018, found in a cohort of 77 patients’ neurologic deficit also did not impact functional recovery.

BENEFITS & HARMS:

Given the available procedures for nerve reconstruction and/or innervated free tissue transfer, nerve injury alone should not predicate salvage versus amputation. However, a known nerve injury (e.g. transection, avulsion, crush, segmental injury) identified at presentation will result in a more complicated reconstructive process for the patient with lower limb trauma. The work group recommends future salvage decisions outside of the acute presentation should be shared with the patient incorporating the risks and benefits of salvage versus amputation. Possible negative sequelae of salvage include lack of motion, lack of sensation and debilitating neuropathic pain.

IMPORTANT/PRIORITY OUTCOMES:

Priority outcomes include a sensate, mobile, stable and nonpainful limb.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

As an independent factor, there is no direct impact on cost effectiveness/resource utilization.

ACCEPTABILITY:

High (not sure)

FEASIBILITY:

High (not sure)

FUTURE RESEARCH:

High powered studies evaluating the impact of the level of nerve injury (with or without reconstruction) on functional outcomes are needed. Long-term outcome studies determining the return of sensation and motor function after reconstructive nerve procedures (e.g. nerve repair, graft, transfer and free soft tissue transfer) are also needed to help set patient and physician expectations in the care of the threatened limb.

Limited evidence suggests that these etiologies may lead to increased risk of adverse events or decreased functional outcomes: Crush Blunt Blast Penetrating Degloving Volumetric muscle loss/soft tissue loss

RATIONALE:

Immediate massive skin and soft tissue loss, and necrosis of crushed or ischemic tissue after injury requiring debridement(s), is not an absolute indication to perform early amputation. Loss of dynamic tissues such as muscle and tendon may compromise function, but anatomic redundancy, compensation, allografts, tendon transfers and bracing can maintain or restore function even in the face of major losses. Massive skin defects can also be managed with free tissue transfers, autografts and allografts and an increasing number of bioengineered membranes. Negative-pressure wound therapy provides temporizing capabilities, promotes intrinsic biologic healing processes and may improve surgical repair success.

Crush injury releasing products of necrosis into the circulatory system may cause renal compromise, multi-system organ failure, circulatory collapse, and death. Despite performing timely surgical intervention or amputation when these problems manifest clinically, irreversible organ damage or death may result. The decision to pursue limb salvage instead of immediate amputation at the time of severe crush injury will sometimes result in avoidable organ loss or death, but these negative outcomes cannot be predicted in an individual patient at the time of injury.

In 2005, MacKenzie et al (as a part of the LEAP study), analyzed 397 patients and showed volumetric muscle loss was associated with a worse Sickness Injury Profile (SIP) score at 84 months after injury, but did not adversely affect limb salvage.

Crush and/or blunt injury was investigated by SM Melton in 1997, TN Hutchison in 2014, and EE Low in 2017, and showed no impact on limb salvage versus amputation. There was a significantly increased risk of pulmonary embolism (PE) (Hutchison) and need for amputation revision (Low) in the 2014 and 2017 studies, which had 1003 and 2314 patients, respectively.

T. Melcer et al (2017) studied 625 patients with lower limb blast injury and showed no impact on limb salvage. Pain and subsequent osteoarthritis were more common in this type of injury, but they found no increases in PE, infection, or osteomyelitis. Penetrating injury did raise the risk of VTE (Hutchison, 2014) 

A. Jain in 2013 looked at lower extremity de-gloving injuries in 40 patients who underwent amputation. This injury type had no significant impact on amputation infection rates.

BENEFITS & HARMS:

Massive muscle and soft tissue loss may complicate or prolong the limb salvage pathway. Ultimate functional outcome may be compromised by the loss of muscle/tendon units and other mechanically important structures.

Cost data clearly show a successful limb salvage patient incurs significantly lower lifetime medical costs compared to amputation.

Some patients with massive soft tissue injury who do not undergo immediate amputation will ultimately have permanent organ failure, septic shock, and/or death. At time zero, there are no factors which can prospectively identify these patients.

OUTCOME IMPORTANCE:

Patients who undergo successful limb salvage will retain a useful extremity, with significantly less lifetime medical expense.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

Successful limb salvage in the setting of severe soft tissue injury may result in higher short-term costs related to multiple surgical procedures, wound management, and prolonged hospitalization. Lifetime medical expenses will be lower compared to amputation.

ACCEPTABILITY:

Pursuing limb salvage in cases of massive soft tissue loss/injury may strain resources at initial point of care, especially in mass-casualty scenarios. Temporizing measures for massive soft tissue injury may be unavailable. Time zero medical personnel may fear being judged retrospectively in cases of ultimate fatality or permanent organ damage in massive crush injuries.

FEASIBILITY:

Adequate resources for massive soft tissue injuries need to be available at initial point of care. These include temporizing coverage options (negative pressure dressings, allograft or engineered tissue coverings) and personnel skilled in wound management using these techniques.

FUTURE RESEARCH:

Studies of attempted limb salvage patients who progress to septic shock, permanent organ damage, and death should focus on predictive tools and clinical and laboratory findings which identify failing limb salvage situations, where timely conversion to amputation prevents organ death and/or patient demise. Studies which look at mechanism of injury, specific and quantifiable anatomic structure soft tissue damage or loss in lower extremity injury, may allow identification of patients at initial presentation who have predictable bad outcomes.

The evidence suggests that neither hard signs of vascular injury nor duration of limb ischemia are absolute factors in the decision for limb salvage vs. amputation. However, the panel recognizes that prolonged ischemia is detrimental and the interval to reperfusion should be kept to a practical minimum. The duration of lower extremity ischemia is directly correlated with adverse events.

RATIONALE:

Six low quality studies examined the effect of various vascular injury on patient outcomes. One study (Asensio, 2006) found that both coagulopathy in the operating room and having two or more hard vascular signs were significantly associated with higher odds of mortality. Hard signs of vascular injury can include the absence of distal pulses, expanding hematoma, palpable thrill, audible bruit and pulsatile bleeding. Additionally, a decrease in the number of patent arteries in the lower leg, was found to be associated with a higher risk of complications in patients as well as a higher risk of take-backs and a higher risk of an increase in total flap failures (Stranix, 2017). Another study (Doucet, 2011) looking at limb ischemia also found it to be predictive of failure of limb salvage. Three additional studies (Jain, 2013, Bennett, 2018, and Melton, 1997) examining ischaemic vascular injury, vascular injury and vein injury, failed to find significance between these factors and infection in the residual limb, AAOS F&A score, and secondary amputation respectively.

The evidence suggests that neither hard signs of vascular injury, nor duration of limb ischemia are absolute factors in the decision as to whether to pursue limb salvage or amputate the injured extremity. However, there is a consensus among the panel that a direct relationship exists between the duration of ischemia and adverse extremity outcomes, including amputation. Therefore, the panel recommends that steps be taken to promptly identify arterial injury and limb malperfusion and to limit the duration of extremity ischemia to a practical minimum. The panel also recommends performance of measures such as extremity fasciotomy and debridement of non-viable tissue to reduce the negative impact of ischemia and reperfusion injury.¹ Additionally, attempts at limb salvage should not be continued in extremities that are unable to have perfusion maintained or restored. Both the available evidence and common sense are clear that when unable to restore or preserve limb perfusion, continued limb salvage efforts are inappropriate and ill-advised.

Arterial injury and extremity ischemia leads to adverse effects including injury to and death of skeletal muscle, peripheral nerves and other soft tissue components. Preclinical research demonstrates that hemorrhagic shock worsens the effect of extremity ischemia and reduces the neuro-muscular ischemic threshold to less than 3 hours.² Recent clinical study from U.S. civilian trauma centers also demonstrates that minimizing the duration of extremity ischemia (to less than 3 hours) is associated with higher rates of limb salvage.³

Pre-clinical and retrospective human study of military and civilian patients confirms the utility of temporary vascular shunts as a damage control adjunct in restoring extremity perfusion.^4,5 In this setting temporary vascular shunts perform best (i.e. stay patent) within a 4-6 hour time window and then are removed at the time of definitive vascular repair. Evidence suggests that vascular shunts are more effective in larger, more proximal extremity vessels, but that they cause no harm when placed as a damage control maneuver in smaller, more distal vessels.4 Clinical consensus is that the use of temporary vascular shunts can be used in certain extremity injury scenarios to limit ischemia and extend the window of successful limb salvage.⁶

Clinical outcomes studies demonstrate that approximately 30-40% of patients who have successful extremity salvage experience poor limb function and diminished quality of life (e.g. chronic pain, limited mobility and need for additional operations).^7-9 Approximately 10-15% of patients who have successful limb salvage during the early phases of care elect to have a secondary amputation of the affected limb in the months and years following injury – most commonly due to chronic pain, recurrent infection or limited function/mobility.^7-9

 

Additional Rationale References:

1. 1. Percival TJ, Rasmussen TE. Reperfusion strategies in the setting of extremity vascular injury with ischemia. Brit J Surg 2012;99(Suppl 1):66-74.
2. 2. Hancock HM, Stannard A, Burkhardt GE, Williams K, Dixon P, Cowart J, Spencer JR, Rasmussen TE. Hemorrhagic shock worsens neuromuscular recovery in a porcine model of hind limb vascular injury and ischemia/ reperfusion. J Vasc Surg 2011;53(4):1052-62.
3. 3. Alarhayem AQ, Cohn SM, Cantu-Nunez O, Eastridge BJ, Rasmussen TE. Impact of time to repair on outcomes in patients with lower extremity arterial injuries. J Vasc Surg. 2019 May;69(5):1519-1523. doi: 10.1016/j.jvs.2018.07.075.
4. 4. Rasmussen TE, Clouse WD, Jenkins DH, Peck MA, Eliason JL, Smith DL. The use of temporary vascular shunts as a damage control adjunct in the management of wartime vascular injury. J Trauma 2006;61(1):15-21.
5. 5. Subramanian A, Vercruysse G, Dente C, Wyrzykowski A, King E, Feliciano DV. A decade's experience with temporary intravascular shunts at a civilian level I trauma center. J Trauma. 2008 Aug;65(2):316-24; discussion 324-6.
6. 6. Gifford SM, Aidinian G, Clouse WD, Fox CJ, Jones WT, Zarzabal L, Michalek JE, Propper BW, Burkhardt GE, Rasmussen TE. Effect of temporary vascular shunting on extremity vascular injury: an outcome analysis from the GWOT vascular initiative. J Vasc Surg 2009;50(3):549-55.
7. 7. Scott DJ, Arthurs ZM, Stannard A, Monroe HM, Clouse WD, Rasmussen TE. Patient-based outcomes and quality of life after salvageable wartime extremity vascular injury. J Vasc Surg 2014;59(1): 173-179.
8. 8. Perkins ZB, Yet B, Glasgow S, Marsh W, Tai NRM, Rasmussen TE. Long-term, patient-centered outcomes of Lower Extremity Vascular Trauma. J Trauma Acute Care Surg. 2018 Jul;85(1S Suppl 2):S104-S111.
9. 9. Sharrock AE, Tai N, Perkins Z, White JM, Remick KN, Rickard RF, Rasmussen TE. Management and outcome of 597 wartime penetrating lower extremity arterial injuries from an international military cohort. J Vasc Surg. 2019 July 70(1):224-232.

Physicians should not consider a patient’s smoking/nicotine use as a critical decision making factor at time zero; Physicians should recommend nicotine education/cessation (abstinence of nicotine) for all patients with high energy lower limb trauma as there is moderate evidence to suggest that smoking/nicotine use has a detrimental effect on outcomes for both amputation and limb salvage.

RATIONALE:

One high quality (MacKenzie, 2006) and three moderate quality (Bosse, 2002; MacKenzie, 2004, 2005) studies revealed significantly worse physical, psychosocial, and overall function measures on the Sickness Index Profile (SIP) among recent and current smokers versus never smokers. Despite the focus of this literature on smoking specifically, the work group recommends cessation of all forms of nicotine given that it is the active ingredient that contributes most to the majority of negative physiological side effects. Physicians should recommend nicotine education/cessation (abstinence of nicotine) for all patients with high energy lower limb trauma and engage in shared decision-making with patients as there is moderate evidence to suggest that smoking/nicotine has a detrimental effect.

BENEFITS/HARMS:

It is well known that smoking has been linked to a multitude of other health risks including, but not limited to multiple cancers, cardiac and pulmonary diseases, PVD, wound complications (including infection), slower bone healing and nonunion, etc. Hence, smoking/nicotine cessation may have multitude of positive effects on outcomes without having any known risks among patients with severe lower extremity trauma regardless of treatment strategy.

IMPORTANT/PRIORITY OUTCOMES:

Successful limb salvage and achieving optimal overall outcomes while minimizing costs/complications are ideal for both patients and health care systems. These ideals will more likely be realized when patients are able to successfully quit smoking/nicotine use.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

Smoking/nicotine cessation has the potential to significantly decrease the costs associated with complications and improve quality of life outcomes in patients with severe lower extremity trauma regardless of treatment strategy. Smoking/nicotine cessation programs are often covered comprehensively by insurers, and thus, little out-of-pocket expense to patients. Therefore, it is likely that smoking/nicotine cessation would prove cost-effective over a life-time to both patients and health care systems.

ACCEPTABILITY:

Most patients, even smokers and users of other nicotine products, will acknowledge that smoking/nicotine may lead to poor general health, and thus, would accept the notion that continued smoking/nicotine use may lead to worse outcomes after severe lower extremity injury.

FEASIBILITY:

There is no evidence to suggest recommending one technique over another for achieving successful smoking/nicotine cessation. Discussion of various techniques is beyond the scope of this paper.

FUTURE RESEARCH:

Defining the incidence of specific complications directly related to smoking/nicotine use for both limb salvage and amputation will enable more detailed physician-patient counseling. Additionally, defining the risk of failure of limb salvage specifically related to smoking/nicotine use could be a powerful adjunct for educating patients undertaking this strategy.

Physicians should not utilize extremity specific scores to select limb salvage vs. amputation, or to predict outcomes for patients with high energy lower extremity trauma.

RATIONALE:

A prospective study from the LEAP group (Bosse 2001) used five injury severity scoring systems (MESS, LSI, PSI>>) to prospectively evaluate 556 patients with lower extremity injuries. At six months from the time of injury 407 patients remained in the limb salvage group. They found that each scoring system was highly specific for amputation, but not sensitive. They concluded that a low score could be used to predict a limb salvage patient, but that a high score could not be used to predict the need for an amputation. This study was not included in the references for the CPG as it did not assess difference in outcomes, however, is relevant to the use of lower extremity injury severity scores at time of injury. While the panel agrees these scores should not be used to guide treatment, they can be useful when used in a descriptive manner and to provide a framework when discussing treatment options with the patient and family.

The same group (Ly, 2008) prospectively evaluated the same five scoring systems to predict outcome following limb salvage using the Sickness Impact Profile (SIP) at 6 months and 2 years after injury. They found that none of the scores were predictive of either the SIP at 6 and 24 months or of the change in SIP between 6 and 24 months. They concluded that these scoring systems should not be used to predict functional outcome following successful limb salvage in patients who sustain a high energy lower-extremity trauma.

A study of 155 military patients with type III open tibia fractures reported that 110 patients underwent successful limb salvage and 45 eventually required amputation. The average MESS scores for these two cohorts were 5.3 and 5.8, respectively; more importantly, MESS scores demonstrated specificity of 87.8% for predicating amputation, but a sensitivity of only 35% and positive predictive value of only 50% for scores ≥7. The authors concluded that MESS scores were neither adequately “sensitive nor accurate for predicting amputation” (Sheean 2014).

BENEFITS & HARMS:

Given that lower extremity scores have not been shown to predict outcomes or the need for amputation or limb salvage, the benefit of implementing this recommendation will be that fewer patients will receive an upfront amputation based on a high extremity specific score such as the MESS or LSI. This should reduce the number of unnecessary amputations. It is possible that a patient with a high MESS, LSI or PSI score may ultimately require an amputation due to other factors and each patient should be evaluated on a case by case basis.

IMPORTANT/PRIORITY OUTCOMES:

Priority outcomes include preventing unnecessary amputations based on tools that have been shown to have a low sensitivity to predict need for amputation.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

As an independent factor, there is no direct impact on cost effectiveness/resource utilization.

ACCEPTABILITY:

High

FEASIBILITY:

High

FUTURE RESEARCH:

Developing a more sophisticated tool for surgeons that incorporates available patient characteristics that has a better sensitivity and specificity in identifying patients who would benefit from an immediate amputation using the body of research from the LEAP studies.

 

Additional Rationale References:

1. Bosse, M.J., MacKenzie, E.J.,Kellam, J.F., et. al. A Prospective Evaluation of the Clinical Utility of the Lower-Extremity Injury-Severity Scores. J Bone Joint Surg Am. 2001; 83(1):3-14.
2. Sheean, A.J., Krueger, C.A., Napierala, M.A., Stinner, D.J., Hsu, J.R. Evaluation of the Mangled Extremity Severity Score in Combat-Related Type III Open Tibia Fracture. J Orthop Trauma. 2014; 28(9):523-6.

 

*Strength of Recommendation: Moderate (upgraded) Evidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. Also requires no or only minor concerns addressed in the EtD framework.

Injury patterns requiring ankle arthrodesis or foot free tissue transfer may be an indication for amputation in the non-acute phase and should be addressed in shared decision making with the patient.

RATIONALE:

Bennett, PM et. al. (2018) performed a study of 114 combat-wounded patients followed for a median of 5 years who sustained 90 fractures. The authors report that, “The median Short-Form 12 physical component score (PCS) of 62 individuals retaining their limb was 45 (IQR 36 to 53), significantly lower than the median of 51 (IQR 46 to 54) in patients who underwent delayed amputation after attempted reconstruction. […] Regression analysis identified three variables associated with a poor F&A score: negative Bohler’s angle on initial radiograph; coexisting talus and calcaneus fracture; and tibial plafond fracture in addition to a hindfoot fracture. The presence of two out of three variables was associated with a significantly lower PCS compared with amputees.”

Bevevino, AJ, et. al performed a study of 155 open calcaneus fractures treated with a “median follow-up 3.5 years and an amputation rate 44%.” Authors employed an “artificial neural network designed to estimate likelihood of amputation, using information available on presentation. For comparison, a conventional logistic regression model was developed with variables identified on univariate analysis. […] Decision curve analysis indicated the artificial neural network resulted in higher benefit across the broadest range of threshold probabilities compared to the logistic regression model.”

Ellington and his colleagues in the LEAP Study Group evaluated the 2-year results of patients with mangled foot and ankle injuries that were treated with “limb salvage surgery that required free tissue flaps for wound closure compared with a similar [group of patients with foot and ankle injury who] underwent early below-knee amputation (BKA).” They evaluated the SIP score (the higher the score, the greater is the disability) and other functional outcome measures such as walking speed, number of rehospitalizations for injury-related complications, time to full weight bearing, the visual analog pain scale, and return to work at 2 years. Their conclusion was that patients with severe foot and ankle injuries who require free tissue transfer or ankle fusion have SIP outcomes that are significantly worse than BKA with the typical skin flap design closure.

Dickens, JF et. al. performed a “retrospective review of 102 combat-related open calcaneal fractures.” Multivariate Cox proportional-hazards regression identified that “blast” being the mechanism of injury and the location and larger size of the open wound, “were predictive of eventual amputation.”

BENEFITS & HARMS:

Desirable anticipated effects are large: the lifetime costs and quality of life for accurate and predictable decision-making are substantial. The undesirable effects consist of amputation OR limb salvage decisions that increase costs, reduce quality, but are largely mitigated with shared decision-making and are lower relative to the desirable effects. Precision in decision making somewhat clearly outweighs the risks.

OUTCOME IMPORTANCE:

Shared decision making has very little downside, and this question is foundational to the entire Practice Guideline; Evidence is sufficient for this relatively discrete set of injury variables to improve arrival at data-based decision making.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

Consideration of prolonged treatment processes includes implant and surgical costs; hospitalizations; recovery duration as well as lifetime disability; emotional and behavioral care costs as well as prostheses/ orthoses.

ACCEPTABILITY:

There will continue to be stakeholders who will refute the available literature for risk to benefit ratio, the costs, and the importance of outcomes.
Potential moral objections to intervention are low in that autonomy and shared decision-making mitigates other ethical principles such as no maleficence, beneficence, or justice.

FEASIBILITY:

Development of a decision tool is feasible to implement and highly important to surgeons and facilities where these injuries are only occasional. This is a sustainable intervention and permits autonomy for providers as well as patients. Barriers include dissemination across various specialties and disciplines

FUTURE RESEARCH:

Foremost will be implementation and validation of this toolkit/ guideline approach. Generalizability and acceptance criteria can be readily developed/ modified and need to be part and parcel of the roll out.

 

Additional Rationale References:

Bevevino, A.J., Dickens, J.F., Potter, B.K., Dworak, T., Gordon, W., Forsberg, J.A. A model to predict limb salvage in severe combat-related open calcaneus fractures. Clin Orthop Relat Res. 2014; 472(10): 3002-9.

In the absence of reliable evidence, the workgroup suggests massive muscle damage requiring extensive debridement is not an absolute factor in the decision for limb salvage vs. amputation.

RATIONALE:

Immediate massive skin and soft tissue loss, and necrosis of crushed or ischemic tissue after injury requiring debridement(s), is not an absolute indication to perform immediate amputation. Loss of dynamic tissues such as muscle and tendon may compromise function, but anatomic redundancy, compensation, allografts, tendon transfers and bracing can maintain or restore function even in the face of major losses. Massive skin defects can also be managed with autografts and allografts and an increasing number of bioengineered membranes. Negative-pressure wound therapy provides temporizing capabilities, promotes intrinsic biologic healing processes and may improve surgical repair success.

Crush injury releasing products of necrosis into the circulatory system may cause renal compromise, multi-system organ failure, circulatory collapse, and death. Despite performing timely surgical intervention or amputation when these problems manifest clinically, irreversible organ damage or death may result. The decision to pursue limb salvage instead of immediate amputation at the time of severe crush injury will sometimes result in avoidable organ loss or death, but these negative outcomes cannot be predicted in an individual patient at the time of injury.

In 2005, MacKenzie et al (as a part of the LEAP study), analyzed 397 patients and showed volumetric muscle loss was associated with a worse Sickness Injury Profile (SIP) score at 84 months after injury, but did not adversely affect limb salvage.

Crush and/or blunt injury was investigated by SM Melton in 1997, TN Hutchison in 2014, and EE Low in 2017, and showed no impact on limb salvage versus amputation. There was a significantly increased risk of pulmonary embolism (PE) (Hutchison) and need for amputation revision (Low) in the 2014 and 2017 studies, which had 1003 and 2314 patients, respectively.

T. Melcer et al (2017) studied 625 patients with lower limb blast injury and showed no impact on limb salvage. Pain and subsequent osteoarthritis were more common in this type of injury, but they found no increases in PE, infection, or osteomyelitis. Penetrating injury did raise the risk of VTE (Hutchison, 2014)
A Jain in 2013 looked at lower extremity de-gloving injuries in 40 patients who underwent amputation. This injury type had no significant impact on amputation infection rates.

BENEFITS & HARMS:

Massive muscle and soft tissue loss may complicate or prolong the limb salvage pathway. Ultimate functional outcome may be compromised by the loss of muscle/tendon units and other mechanically important structures.

Cost data clearly show a successful limb salvage patient incurs significantly lower lifetime medical costs compared to amputation.
Some patients with massive soft tissue injury who do not undergo immediate amputation will ultimately have permanent organ failure, septic shock, and/or death. At time zero, there are no factors which can prospectively identify these patients.

OUTCOME IMPORTANCE:

Patients who undergo successful limb salvage will retain a useful extremity, with significantly less lifetime medical expense.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

Successful limb salvage in the setting of severe soft tissue injury may result in higher short-term costs related to multiple surgical procedures, wound management, and prolonged hospitalization. Lifetime medical expenses will be lower compared to amputation.

ACCEPTABILITY:

Pursuing limb salvage in cases of massive soft tissue loss/injury may strain resources at initial point of care, especially in mass-casualty scenarios. Temporizing measures for massive soft tissue injury may be unavailable. Time zero medical personnel may fear being judged retrospectively in cases of ultimate fatality or permanent organ damage in massive crush injuries.

FEASIBILITY:

Adequate resources for massive soft tissue injuries need to be available at initial point of care. These include temporizing coverage options (negative pressure dressings, allograft or engineered tissue coverings) and personnel skilled in wound management using these techniques.

FUTURE RESEARCH:

Studies of attempted limb salvage patients who progress to septic shock, permanent organ damage, and death should focus on predictive tools and clinical and laboratory findings which identify failing limb salvage situations, where timely conversion to amputation prevents organ death and/or patient demise. Studies which look at mechanism of injury, specific and quantifiable anatomic structure soft tissue damage or loss in lower extremity injury, may allow identification of patients at initial presentation who have predictable bad outcomes.

In the absence of reliable evidence, it is the consensus of the work group that all patients with lower extremity amputation be fitted with an appropriate prosthesis. Likewise, all lower extremity limb salvage patients with residual deficits should be evaluated for and/or fitted with an appropriate orthosis. These conditions are lifelong and require periodic reevaluation and device adjustments and/or replacement.

RATIONALE:

The complexity of psychosocial and medical variables relevant to lower limb amputation and lower limb salvage patients inhibit the ability to provide the direct impact of orthotics/prosthetics. However, appropriately crafted and fitted Orthotics/prosthetics are intertwined with the patient's quality of life, return to work, physical functioning, residual limb skin health, and pain. The holistic approach to treating, managing, and supporting the patient's desired level of function after a lower limb amputation or salvage procedure requires regular adjusting or replacing of orthotics/prosthetics for the patient to maintain optimal physical function and health.

BENEFITS & HARMS:

Patients' with comfortably fitting orthotics/prosthesis trend towards longer periods of orthotic/prosthesis use and higher rates of return to work. Residual limb skin health is an omnipresent challenge; appropriately fitted and maintained prosthesis are essential to preserving the residual limb skin health and potentially preserving future limb length.

COST EFFECTIVENESS:

Evidence indicates increased lifelong cost with lower limb amputation primarily as a result of prosthesis maintenance and replacements. There is no indication that poorly fitting or maintained prosthesis/orthotics are cost effective, improve compliance, reduce residual limb skin health complications, or improve the patient's function and quality of life; appropriately fitted, maintained, and regular orthotic/prosthesis replacement is more likely to support the holistic treatment and improve the physical function of lower limb amputee and lower limb salvage patients.

In the absence of reliable evidence, it is the opinion of the work group that pre-existing comorbid conditions should be considered in the decision of limb salvage vs amputation.

RATIONALE:

Consensus opinion was reached by the work group based on the argument that limiting surgical exposures (early amputation) would likely minimize complications and increase cost-effectiveness in patients with severe and/or multiple comorbidities (COPD, PVD, CHF, valvular disease, ESRD, liver failure, dementia, etc.) who may not tolerate multiple surgeries when pursuing limb salvage.

BENEFITS & HARMS:

Minimizing the numbers of surgeries in patients with severe comorbidities will potentially minimize the risk of perioperative complications including, but not limited to death, re-admissions, increased length-of-stay (LOS), wound complications, infection/sepsis, VTE, and serious cardiopulmonary and renal complications. Certainly, overestimating the number and/or severity of comorbidities at time zero could lead to premature amputation outside the purview of life-over-limb scenarios.

IMPORTANT/PRIORITY OUTCOMES:

Death, re-admissions, increased LOS, wound complications, infection/sepsis, VTE, and serious cardiopulmonary and renal complications are all well-known negative outcomes that surgeons seek to avoid in attempting to provide high quality care and increased quality of life for their patients. Additionally, they have become well-known metrics by which health care organizations are benchmarked for quality of care.

COST EFFECTIVENESS/RESOURCE UTILIZATION:

Literature supports that lifetime costs of amputation are higher for young patients with diminishing costs approaching that of limb salvage when performed in patients with decreased life expectancy. Under the assumption that patients with severe and/or multiple comorbidities would more likely be older and experience more complications with attempted limb salvage, appropriate early amputation may be the more cost-effective strategy among these patients.

ACCEPTABILITY:

Some people groups may approach the limb salvage versus amputation dilemma with a “limb salvage at all cost” philosophy. However, it is believed that most patients will choose an interactive, rationalized decision-making approach when presented with reasonable evidence and medical facts about their pre-existing health by their surgeon in order to make the most appropriate choice for them.

FEASIBILITY:

Outside of the life-over-limb scenario, informed medical decision-making is the standard of care. Taking into account the type, number, combination, and/or severity of comorbidities and their potential effects on outcomes will promote this process.

FUTURE RESEARCH:

Studies focused on understanding the specific type, number, combination, and/or severity of comorbidities effects on a multitude of outcomes will allow us to make more definitive future recommendations with regards to their influence on the decision for limb salvage versus amputation.