New randomized controlled trial shows that addition of Smith+Nephew's REGENETEN™ Bioinductive Implant delivers 86% reduction in rotator cuff re-tear rates at 12 months
The multicentre, triple-blinded RCT results were presented last week by Prof. Miguel Angel Ruiz-Ibán, MD., PhD., Hospital Universitario Ramon Y Cajal,
At 12 months follow-up, repairs with the added REGENETEN Bioinductive Implant resulted in significantly lower re-tear rates than those with a TOE repair alone (p= 0.022). Specifically, the RCT reported:
- Patients who received a REGENETEN Bioinductive Implant presented a retear rate of 3.5%. (n=29)
- Patients who received a TOE repair alone presented a re-tear rate of 25% which is in-line with published re-tear rates on similar tear types.1,2 (n=28)
There were no differences in postoperative complications between groups.
"Traditional rotator cuff procedures and the resulting re-tear rates present a challenge and a concern for both surgeons and patients alike," commented Prof. Ruiz-Ibán. "The interim results from this RCT are encouraging and indicate that the Smith+Nephew REGENETEN Bioinductive Implant may significantly improve re-tear rates. I look forward to the completion of this investigation in 2023 and further use of the implant."
With the potential to aid approximately 545,000 annual rotator cuff procedures, globally3, the REGENETEN Bioinductive Implant provides a patient centric treatment supporting the body's natural healing response to facilitate healing of rotator cuff tears.4-8 With at least 12 published clinical studies including 709 patients5,9-18,20, the REGENETEN implant has been shown to change the course of tear progression in early studies5-7,19, aid return to normal activity19 and reduce re-tears versus conventional surgery.20,21
"New RCT evidence supporting the use of our REGENETEN™ Bioinductive Implant for improved patient outcomes continues to grow," said
The REGENETEN Bioinductive Implant is part of Smith+Nephew's comprehensive Advanced Healing Solutions portfolio - redefining biological healing in rotator cuff repair along with expanded applications for Gluteus Medius and Achilles tears.* To learn more about the REGENETEN Bioinductive Implant, please click here.
- Kim Y-S, Lee H-J, Jin H-K, Kim S-E, Lee J-W. Conventional En Masse Repair Versus Separate Double-Layer Double-Row Repair for the Treatment of Delaminated Rotator Cuff Tears.
The American Journal of Sports Medicine. 2016;44(5):1146-1152
- Hein J, Reilly JM, Chae J, Maerz T, Anderson K. Retear Rates After Arthroscopic Single-Row, Double-Row, and Suture Bridge Rotator Cuff Repair at a Minimum of 1 Year of Imaging Follow-up: A Systematic Review. Arthroscopy. 2015 Nov;31(11):2274-81.
Smith + Nephewinternal data analysis derived from Decision Resources Group, Global Report 2018 & SmartTRAK DATA Analytics 2022
- Van Kampen C, Arnoczky, S, Parks, P, et al. Tissue-engineered augmentation of a rotator cuff tendon using a reconstituted collagen scaffold: A histological evaluation in sheep. MLTJ. 2013;3(3):229-235
- Bokor DJ, Sonnabend D, Deady L, et al. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscles, Ligaments Tendons J 2016;6(1):16-25.
- Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP. Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multicenter study. J Shoulder Elbow Surg. 2018 27(2):242-251
- Bokor DJ, Sonnabend DH, Deady L, et al. Healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a highly porous collagen implant: a 5-year clinical and MRI follow-up. Muscles, Ligaments Tendons J 2019;9(3):338-347.
- McElvany MD, McGoldrick E, Gee AO, Neradilek MB, Matsen FA, 3rd. Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med. 2015;43(2):491-500.
- McIntyre LF, McMillan S, Trenhaile SW, Bishai SK, Bushnell BD. Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry. Arthrosc Sports Med Rehabil. 2021 Aug 20;3(5):e1473-e1479
- Bushnell BD, Connor P, Harris HW, Ho CP, Trenhaile SW, Abrams JS. Two-year outcomes with a bioinductive collagen implant used in augmentation of arthroscopic repair of full-thickness rotator cuff tears: Final results of a prospective multi-center study. J Shoulder Elbow Surg. 2022 Jul 1:S1058-2746
- Micheloni GM, Salmaso G, Zecchinato G, Giaretta S, Barison E, Momoli A. Bio-inductive implant for rotator cuff repair: our experience and technical notes. Acta Biomed. 2020 Dec 30;91(14-S)
- Thon SG, O'Malley L 2nd, O'Brien MJ, Savoie FH 3rd. Evaluation of Healing Rates and Safety With a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes. Am J Sports Med. 2019 Jul;47(8):1901-1908
- Arnoczky SP,
Bishai SK, Schofield B, Sigman S, Bushnell BD, Hommen JP, Van Kampen C. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017 Feb;33(2):278-283
- Camacho-Chacon JA, Cuenca-Espierrez J,
Roda-Rojo V, Martin-Martinez A, Calderon-Meza JM, Alvarez-Alegret R, Martin-Hernandez C. Bioinductive collagen implants facilitate tendon regeneration in rotator cuff tears. J Exp Orthop. 2022 Jun 8;9(1):53
- Bushnell BD, Bishai SK, Krupp RJ, McMillan S, Schofield BA, Trenhaile SW, McIntyre LF. Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry. Orthop J Sports Med. 2021 Aug 13;9(8
- Dai A, Campbell A, Bloom D, Baron S, Begly J, Meislin R. Collagen-Based Bioinductive Implant for Treatment of Partial Thickness Rotator Cuff Tears.
Bull Hosp Jt Dis(2013). 2020 Sep;78(3):195-201
- Schlegel TF, Abrams JS, Angelo RL, Getelman MH, Ho CP, Bushnell BD. Isolated bioinductive repair of partial-thickness rotator cuff tears using a resorbable bovine collagen implant: two-year radiologic and clinical outcomes from a prospective multicenter study. J Shoulder Elbow Surg. 2021 Aug;30(8):1938-1948
- Yeazell S, Lutz A, Bohon H, Shanley E, Thigpen CA, Kissenberth MJ, Pill SG. Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial. J Shoulder Elbow Surg. 2022 Jun;31(6S):S131-S135
- McIntyre L, Bishai SK, Brown PB, Bushnell BD, Trenhaile SW. Patient-Reported Outcomes Following Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. Arthroscopy. 2019 35(8):2262-2271
- Bokor DJ, Sonnabend D, Deady L et al. Preliminary investigation of a biological augmentation of rotator cuff repairs using a collagen implant: a 2-year MRI follow-up. MLTJ. 2015;5(3):144-150
- Smith + Nephew 2019. An overview of the outcomes associated with the standard of care for the surgical treatment of rotator cuff tears. Internal Report EO/SPM/REGENETEN/005/v1.
*The REGENETEN implant is currently approved for use in treating Gluteus Medius and Achilles tears only in the
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