Two high quality studies have addressed bioinductive collagen-based tendon implants. Ruiz Iban studied 124 patients with medium to large rotator cuff tears in a randomized clinical trial of double row rotator cuff repair with and without bioinductive tendon implant augmentation and found a significantly lower retear rate with augmentation, though functional outcomes did not demonstrate any differences. Camacho Chacon performed a RCT of 60 patients with smaller tears and an intact rotator cable. This study compared double row repair with primary repair using only the bioinductive tendon implant. They found better functional outcomes, a lower retear rate, and higher quality tendon tissue on biopsy with bioinductive tendon implant repair. They also noted faster return to work in the tendon implant group.
Risks and Harms of Implementing this Recommendation
The use of bioinductive tendon implants increases operating time and thus may increase infection rates and other surgical time-related complications. Use of bioinductive tendon implants may 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 devices.
- Camacho Chacon, J. A., Roda Rojo, V., Martin Martinez, A., Cuenca Espierrez, J., Garcia Calvo, V., Calderon Meza, J. M., Martin Hernandez, C. An isolated bioinductive repair vs. sutured repair for full-thickness rotator cuff tears: 2-year results of a double blinded, randomized controlled trial. Journal of Shoulder & Elbow Surgery 2024; 0: 09
- Ruiz Iban, M. A., Garcia Navlet, M., Moros Marco, S., Diaz Heredia, J., Hernando Sanchez, A., Ruiz Diaz, R., Vaquero Comino, C., Rosas Ojeda, M. L., Del Monte Bello, G., Avila Lafuente, J. L. Augmentation of a Transosseous-Equivalent Repair in Posterosuperior Nonacute Rotator Cuff Tears With a Bioinductive Collagen Implant Decreases the Retear Rate at 1 Year: A Randomized Controlled Trial. Arthroscopy 2024; 6: 1760-1773