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Clinical Evidence

 

New RCT data shows faster early recovery and successful healing

Recovery is just as important as the repair for partial-thickness tears, so new randomized controlled trial (RCT) data is a strong signal for the future standard of care. The results show attention-grabbing advantages for patients treated with the REGENETEN Implant as isolated bioinductive repair (with accelerated REGENETEN Implant physical therapy protocol), compared to traditional takedown and repair.

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Evidence-based advantages of using the REGENETEN Implant

  • 65% lower risk of re-tear at 2 years after full-thickness tear repair.*1
  • Accelerated recovery and return to activity.**2,3
  • Provides consistent tendon healing in isolated bioinductive repair or as an augment.4-8
  • Induces new tendon-like tissue growth4-6,9 and shown to increase tendon thickness.4,5,7,10
  • Resorbed and replaced by approximately 2mm of new tendon-like tissue within 6 months.2,4,9,11-13
  • Efficient and suture-free technique.***14
  • Backed by a decade of clinical evidence.4,15
  • Shown to result in post-operative improvements in pain.15
  • Consistent improvements in pain and functional outcomes across articular-sided, bursal-sided and intra-substance tears in 1- and 2-year results.****13
  • Meaningful improvements in pain and function (SANE) scores at 1 year, compared to pre-operation.3,16,17
  • AAOS rotator cuff clinical practice guidelines (CPG) for bioinductive implants based on REGENETEN Implant data.18 
  • Resulted in functional recovery times halved, high tendon healing rates and earlier improvements in quality of life when used as isolated treatment for partial-thickness tears, using an accelerated REGENETEN Implant rehabilitation protocol (vs traditional repairs).19
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Disclaimers

*Compared to standard repairs alone, p=0.004. RR = 0.35 (95% CI: 0.161-0.762).

**Compared to takedown and (suture anchor) repair

***Mean 13.9 minute to implant REGENETEN.

****In 1-and 2-year results; n=31.

Postoperative care, including physical therapy, is individualized and is determined by the healthcare provider based on the patient's symptoms, injury pattern, unique patient anatomy, patient medical history, and individual treatment requirements. Not all patients will have the same surgical procedure or timelines for rehabilitation.

The REGENETEN Bioinductive implant is cleared for use on any tendon where there is not substantial loss of tendon tissue. REGENETEN Bone Anchors are only indicated for use in rotator cuff repair. Published clinical outcomes are for rotator cuff. Please also include disclaimer to refer to IFU for product indications for use.

Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Smith+Nephew representative or distributor if you have questions about the availability of Smith+Nephew products in your area. For detailed product information, including indications for use, contraindications, precautions and warnings, please consult the product’s applicable Instructions for Use (IFU) prior to use.

Citations
  1. Ruiz Iban MA, et al. Arthroscopy, 2025; 44(10): 3869-3879.
  2. Camacho Chacón JA, et al. J Shoulder Elbow Surg. 2024;33(9):1894-1904.
  3. Bushnell BD, et al. Orthop J Sports Med. 2021;9(8):23259671211027850.
  4. Bokor DJ, et al. Muscles Ligaments Tendons J. 2016;6(1):16-25.
  5. Schlegel TF, et al. J Shoulder Elbow Surg. 2018; 27(2):242-251.
  6. Thon SG, et al. Am J Sports Med, 2019; 47(8): 1901-1908.
  7. Bokor DJ, et al. Muscles Ligaments Tendons J. 2015;5(3):144-150.
  8. Ruiz Ibán MÁ, et al. Journal of Arthroscopic & Related Surgery, 2023: 1-14.
  9. Van Kampen C, et al. Muscles Ligaments Tendons J. 2013;3(3):229-235.
  10. Bokor DJ, et al. Muscles Ligaments Tendons J. 2019;9(3):338-347.
  11. Arnoczky SP, et al. Arthroscopy. 2017;33(2):278-283.
  12. Camacho-Chacon JA, et al. J Exp Orthop. 2022;9(1):53.
  13. Schlegel TF, et al. J Shoulder Elbow Surg. 2021;30(8):1938-1948.
  14. Ruiz Ibán MÁ, et al. Arthroscopy. 2024;40(6):1760-1773.
  15. Warren JR, et al. J Shoulder Elbow Surg. 2024;33(11):2515-2529.
  16. Cvetanovich GL, et al. J Shouler Elbow Surg. 2019;28(5):939-948.
  17. McIntyre LF, et al. Arthrosc Sports Med Rehabil. 2021;3(5):e1473-e1479. 
  18. American Academy of Orthopedic Surgeons (AAOS). Rotator Cuff Repair Clinical Practice Guideline. Available here. [Accessed February 2026].
  19. Wang A, et al. Orthop J Sports Med. 2026;14(3):23259671261418675.

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