Presented at the AOSSM-AANA Combined 2021 Annual Meeting, study investigators compared the use of a REGENETEN Implant alone (without surgical repair) to a REGENETEN Implant plus traditional surgical repair for the treatment of partial-thickness rotator cuff tears in 227 patients across 19 US surgical centers.
Key findings of the study included:
Compared with traditional surgical repair, patients reported a significant improvement in shoulder function in the early post-operative period (weeks 2 and 6) with the REGENETEN Implant alone
Treatment with the REGENETEN Implant alone demonstrated equivalent efficacy to REGENETEN plus traditional surgical repair with minimal revisions across both treatment groups at 1 year
Among all patients receiving a REGENETEN Implant, patients reported significant improvements in pain, function and quality of life from at 1 year compared with pre-surgery values
'The results of this pioneering study show that using REGENETEN alone simplifies the surgical procedure. It is less invasive and can potentially lower risk of complications when compared with the current standard of care,' said Dr.
Smith+Nephew's collagen-based REGENETEN Bioinductive Implant supports the body's natural healing response by inducing the growth of new tendon-like tissue2-5 to biologically augment the existing tendon and disrupt disease progression.2-6 Delivered arthroscopically through a small incision over the location of the rotator cuff tendon injury, the implant is about the size of a postage stamp and is completely resorbed within six months.4,7
'Since its introduction in 2014, the REGENETEN Implant has had a transformative impact on the way surgeons approach rotator cuff procedures,' said
Smith+Nephew's REGENETEN Bioinductive Implant is available in the US,
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References
1. Bushnell BD, et al. Treatment of partial-thickness rotator cuff tear repairs with a resorbable bioinductive bovine collagen implant: 1-year results from a prospective multi-center registry. Presented at: AOSSM-AANA Combined 2021 Annual Meeting,
2. 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.
3. 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.
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. Muscles Ligaments Tendons J. 2013;3(3):229-235.
5. 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.
6. 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.
7. Arnoczky SP,
About Smith+Nephew
Smith+Nephew is a portfolio medical technology business that exists 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, Advanced Wound Management and Sports Medicine & ENT.
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