Michael Barbella, Managing Editor01.11.24
Smith+Nephew today released promising results for its REGENETEN Bioinductive Implant from a recently completed randomized controlled trial (RCT). Published online last month in Arthroscopy, the report concluded that at one-year, medium and large full-thickness rotator cuff tears repaired and augmented with the REGENETEN Bioinductive Implant had better tendon healing compared to the standard of care,1 as evidenced by:
“Rotator cuff repair is traditionally associated with re-tear rates in excess of 20%, presenting a challenge for surgeons and patients alike," said Dr. Miguel Ruiz Ibán, head of the Shoulder and Elbow Unit at Hospital Universitario Ramón y Cajal in Madrid, Spain, and the study's principal investigator. "This RCT demonstrates that the REGENETEN Bioinductive Implant substantially and significantly reduced this risk. With no increase in complications seen in our study, these findings support the use of the implant to reduce re-tear rates in the population studied.”
With more than 100,000 procedures completed globally since its introduction in 2014, the REGENETEN Bioinductive Implant has had a transformative impact, offering a better solution for more than 1 million2 people who annually undergo surgery for rotator cuff tears. The collagen-based implant supports the body’s natural healing response to facilitate the formation of new tendon-like tissue to biologically augment the existing tendon and change the course of rotator cuff tear progression.1,3-8
“Smith+Nephew is committed to proving the value of our technology through support for clinical evidence generation,” stated Christie Van Geffen, senior vice president of Sports Medicine Global Marketing at Smith+Nephew. “We are pleased and excited by the opportunity presented by this evidence to drive adoption of, and access to, the REGENETEN Bioinductive Implant. Our goal is to help surgeons improve the care of many more patients with rotator cuff injuries.”
The REGENETEN Bioinductive Implant is part of Smith+Nephew’s Advanced Healing Solutions portfolio.
Smith+Nephew is a portfolio medical technology company focused on the repair, regeneration and replacement of soft and hard tissue. It employs 19,000 workers and commercializes new technologies across its three global business units: Orthopaedics, Sports Medicine & ENT and Advanced Wound Management. Founded in Hull, U.K., in 1856, the company now operates in more than 100 countries, and generated annual sales of $5.2 billion in 2022.
References
1 Ruiz Ibán MA, Navlet MG, Marco SM, et al. Augmentation of a transosseous equivalent repair in posterosuperior non-acute rotator cuff tears with a bioinductive collagen implant decreases the re-tear rate at one year. A randomised controlled trial. Arthroscopy. Published online 12/27/2023.
2 iData Research. Rotator cuff repair and reconstruction market size, share and trends analysis (2023). Available at: https://idataresearch.com/product/rotator-cuff-repair-reconstruction-market-size-share-and-trends-analysis-global-2023-2029-medsuite-includes-grafts-allografts-xenograft-synthetic-and-1-more/#. Accessed December 19, 2023.
3 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.
4 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.
5 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. Muscles Ligaments Tendons J. 2013;3(3):229-235.
6 Arnoczky SP, Bishai SK, Schofield B, et al. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017;33(2):278-283
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.
- A significantly lower re-tear rate (8.3% vs 25.8%; p=0.01)
- A three times lower risk of re-tear (RR=0.32; 95% CI:0.13–0.83)
- No difference in serious or minor complications totals
“Rotator cuff repair is traditionally associated with re-tear rates in excess of 20%, presenting a challenge for surgeons and patients alike," said Dr. Miguel Ruiz Ibán, head of the Shoulder and Elbow Unit at Hospital Universitario Ramón y Cajal in Madrid, Spain, and the study's principal investigator. "This RCT demonstrates that the REGENETEN Bioinductive Implant substantially and significantly reduced this risk. With no increase in complications seen in our study, these findings support the use of the implant to reduce re-tear rates in the population studied.”
With more than 100,000 procedures completed globally since its introduction in 2014, the REGENETEN Bioinductive Implant has had a transformative impact, offering a better solution for more than 1 million2 people who annually undergo surgery for rotator cuff tears. The collagen-based implant supports the body’s natural healing response to facilitate the formation of new tendon-like tissue to biologically augment the existing tendon and change the course of rotator cuff tear progression.1,3-8
“Smith+Nephew is committed to proving the value of our technology through support for clinical evidence generation,” stated Christie Van Geffen, senior vice president of Sports Medicine Global Marketing at Smith+Nephew. “We are pleased and excited by the opportunity presented by this evidence to drive adoption of, and access to, the REGENETEN Bioinductive Implant. Our goal is to help surgeons improve the care of many more patients with rotator cuff injuries.”
The REGENETEN Bioinductive Implant is part of Smith+Nephew’s Advanced Healing Solutions portfolio.
Smith+Nephew is a portfolio medical technology company focused on the repair, regeneration and replacement of soft and hard tissue. It employs 19,000 workers and commercializes new technologies across its three global business units: Orthopaedics, Sports Medicine & ENT and Advanced Wound Management. Founded in Hull, U.K., in 1856, the company now operates in more than 100 countries, and generated annual sales of $5.2 billion in 2022.
References
1 Ruiz Ibán MA, Navlet MG, Marco SM, et al. Augmentation of a transosseous equivalent repair in posterosuperior non-acute rotator cuff tears with a bioinductive collagen implant decreases the re-tear rate at one year. A randomised controlled trial. Arthroscopy. Published online 12/27/2023.
2 iData Research. Rotator cuff repair and reconstruction market size, share and trends analysis (2023). Available at: https://idataresearch.com/product/rotator-cuff-repair-reconstruction-market-size-share-and-trends-analysis-global-2023-2029-medsuite-includes-grafts-allografts-xenograft-synthetic-and-1-more/#. Accessed December 19, 2023.
3 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.
4 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.
5 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. Muscles Ligaments Tendons J. 2013;3(3):229-235.
6 Arnoczky SP, Bishai SK, Schofield B, et al. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017;33(2):278-283
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.