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

LONDON, Sept. 14, 2022 /PRNewswire/ -- Smith+Nephew (LSE:SN, NYSE: SNN), the global medical technology company, today announces promising new data furthering a number of published studies supporting the use of its REGENETEN Bioinductive Implant in rotator cuff repair. Interim analysis from a randomized controlled trial (RCT) shows a significant reduction in the re-tear rate of full-thickness rotator cuff repairs when using the REGENETEN Bioinductive Implant.

The multicentre, triple-blinded RCT results were presented last week by Prof. Miguel Angel Ruiz-Ibán, MD., PhD., Hospital Universitario Ramon Y Cajal, Madrid Spain, at the 2022 SECEC-ESSE Congress in Dublin, Ireland. Re-tear rates of patients with medium to large full-thickness tears were measured following either an arthroscopic supraspinatus transosseous equivalent (TOE) repair alone, or the same TOE repair with the addition of a REGENETEN Bioinductive Implant.

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:

1. Patients who received a REGENETEN Bioinductive Implant presented a retear rate of 3.5%. (n=29)
2. 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 patients^5,9-18,20, the REGENETEN implant has been shown to change the course of tear progression in early studies^5-7,19, 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 Christie Van Geffen, VP Sports Medicine Joint Repair at Smith+Nephew. "No other bioinductive treatment has the amount of science behind it supporting the clinical value for thousands of patients with rotator cuff tears."  

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.

References

1. 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
2. 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.
3. Smith + Nephew internal data analysis derived from Decision Resources Group, Global Report 2018 & SmartTRAK DATA Analytics 2022
4. 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
5. 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.
6. 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
7. 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.
8. 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.
9. 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
10. 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
11. 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)
12. 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
13. 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
14. 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
15. 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
16. 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
17. 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
18. 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
19. 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
20. 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
21. 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 U.S.

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people's bodies and their self-belief by using technology to take the limits off living. We call this purpose 'Life Unlimited'. Our 18,000 employees deliver this mission every day, making a difference to patients' lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global franchises of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.

Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.2 billion in 2021. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE: SNN). The terms 'Group' and 'Smith+Nephew' are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on Twitter, LinkedIn, Instagram or Facebook.

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