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1 May 2025

Is there a new standard of care for rotator cuff repair?

REGENETEN BLOGS   ·   5 min read


Insights from a recently published randomised controlled trial (RCT) showing reduced re-tears in full-thickness tears with REGENETEN◊ Bioinductive Implant


Key takeaways:

  • Rotator cuff repairs are a common procedure, but challenges remain with up to 1 in 4 patients experiencing a re-tear
  • Augmentation of rotator cuff repair presents a solution to address the biological challenges, but high-level evidence has been lacking until recently
  • Now an RCT has been published with 2-year results comparing medium and large full-thickness rotator cuff repair with and without augmentation using the REGENETEN Implant
  • Post hoc analysis showed patients with healed tendons had significantly better clinical outcomes, compared to those with re-tears
  • The study investigators concluded that repairs augmented with the REGENETEN Implant were shown to significantly reduce the risk of re-tear, meaning patients have a higher likelihood of the tendon healing leading to better clinical outcomes, without increasing complications


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Rotator cuff repairs are one of the most frequently performed procedures. In 2024, approximately 750,000 rotator cuff repairs were completed in the US alone and that number is expected to increase by 5% each year.1 This commonly performed procedure still comes with its challenges though, as it’s not uncommon for up to 20–25% of patients to experience a re-tear.2



Greater understanding of re-tears highlights the need for augmentation in repair

Traditional surgical techniques focus on the mechanical aspects of the repair, aiming to keep the tendon in close contact to the bone. However, despite advances in biomechanics, failed healing remains common. Factors thought to drive failed healing and re-tears include those related to the patient's underlying biology and tendon quality. New solutions aim to address both the biological and biomechanical challenges of rotator cuff repair to aid healing.

Over the last decade, augmentation of rotator cuff repair has gained momentum and presents a solution to address the biological challenges of rotator cuff repair. However, high level evidence, like randomised controlled trials (RCTs), has been lacking until recently.

Dr. Miguel Ruiz Ibán (Head of the Shoulder and Elbow Unit in the Department of Orthopedic Surgery and Traumatology in Hospital Universitario Ramón y Cajal, in Madrid, Spain) and his colleagues observed that rotator cuff augments were gaining in popularity and wanted to see how they compared against the current standard of care.



RCT: the methodology, design and execution3

Recently, the RCT has been published with 2-year results comparing rotator cuff repair with and without augmentation using the REGENETEN Bioinductive Implant in medium and large (1–4cm) full-thickness tears. 124 patients were randomised into two groups, one group had an arthroscopic posterosuperior rotator cuff tear transosseous equivalent (TOE) repair (Control group) and the other group had the same repair augmented with the REGENETEN Bioinductive Implant (REGENETEN Implant group). There were no relevant differences in the pre-operative demographic and clinical characteristics between groups.

The primary outcome was tendon integrity assessed on MRI using the Sugaya classification (considering grades ≤3 as healed; ≥4 as re-tears). Secondary outcomes included re-tear location assessed on MRI and clinical outcomes including pain levels and measures of function, quality of life and post-op recovery, all assessed at 2-year follow-up. A post hoc analysis focused on patient outcomes in those with healed tendons versus re-tears.



Significantly lower re-tear rates with the REGENETEN Implant3

114 of the original 124 patients were available for MRI evaluation and clinical follow-up at 2 years (57 patients each group).


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Abbreviations: CI = confidence interval; RR = risk ratio.


Tendon integrity, the primary outcome, was significantly better in the REGENETEN Implant group, compared to the control group.* The re-tear rate was significantly lower in the REGENETEN Implant group, compared to the control group.† Augmenting repair with the REGENETEN Implant was shown to reduce the risk of re-tear by 65%, compared to the control group.‡ The number needed to treat with the REGENETEN Implant to avoid a re-tear was 4.4.§

Watch Dr. Ruiz Ibán talk about how a healed tendon provides better outcomes for the patient in the long-term:

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Patients with healed tendons had significantly better clinical outcomes, compared to those with re-tears3



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A post hoc analysis found that, in both groups, patients with healed tendons (n=87) presented significantly lower pain and significantly better clinical scores compared to patients with re-tears (n=25). When considering that TOE repairs augmented with the REGENETEN Bioinductive implant in medium and large full-thickness rotator cuff tears were shown to significantly reduce the risk of retear, patients have a higher likelihood of the tendon healing, leading to better clinical outcomes, without increasing complication rates.


This finding supports the theory that a healed tendon will lead to better clinical outcomes for patients after rotator cuff repair. Studies have shown improved clinical and functional outcomes for patients with healed rotator cuff tears compared to those who have experienced – re-tears, particularly when data is assessed in the longer term.4–7



This RCT is a great step towards the REGENETEN Implant becoming standard of care. What could these outcomes do for your patients?

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Read the full publication. Find out more about the REGENETEN Implant’s evidence base.

20250428_BlogRuizIban_Evidence

The REGENETEN Bioinductive Implant: revolutionizing rotator cuff repair

The REGENETEN Bioinductive Implant is a highly porous scaffold made from purified type I collagen fibers.8 Following fixation it induces the formation of ~2mm of tendon-like tissue and is absorbed by the body within 6 months.9–14 The REGENETEN Implant has been used in more than 150,000 patientsǁ with tendon injuries including in partial- and full-thickness rotator cuff tears.



REGENETEN implant on RCR image from animation

Find out more about the REGENETEN Implant:

REGENETEN for patients. 

REGENETEN for healthcare professionals. 

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References

* 87.7% (50/57) of the REGENETEN group achieved Sugaya grade ≤3 versus 64.9% (37/57) of the control group (p=0.020).

† 12.3% in the REGENETEN group versus 35.1% of the control group (p=0.004).

‡ RR: 0.35; 95% CI (confidence interval): 0.16–0.76.

§ 95% CI: 2.6–12.9.

Pain (p=0.0068); CMS (p=0.0069); ASES score (p=0.0150).

ǁ Based on Smith+Nephew internal sales data, from 2014 to 2024.



This information is for educational and informational purposes only, and may not be appropriate for all jurisdictions. This information does not constitute and is not intended to be medical advice. Smith+Nephew does not provide medical advice. It is the treating health care provider’s responsibility to determine the best course of treatment for their patient based upon their professional medical judgment. For detailed information, including indications for use, contraindications, effects, precautions and warnings, please consult the product’s Instructions for Use (IFU) prior to use.


Citations
  1. SmartTRAK Market report on shoulder soft tissue fixation - US, 2024. Prepared November 2024.
  2. Hein J, et al. Arthroscopy. 2015;31(11):2274–2281.
  3. Ruiz Ibán MA, et al. Arthroscopy. Published online April 11, 2025. doi:10.1016/j.arthro.2025.03.057.
  4. Holtedahl R, et al. J Shoulder Elbow Surg. 2023;32:1333–46.
  5. Vastamäki M, et al. Clin Orthop Relat Res. 2013;471(2):554–561.
  6. Haque A, et al. Shoulder Elbow. 2018;10(3):163–169.
  7. Kim HM, et al. JBJS Open Access. 2014;96(2):106–112.
  8. Smith + Nephew 2020 REGENETEN Collagen Implant Physical Characteristics. Internal Report.
  9. Camacho-Chacon JA, et al. J Exp Orthop. 2022;9(1):53.
  10. Camacho Chacón JA, et al. J Shoulder Elbow Surg. 2024;33(9):1894–1904.
  11. Bokor DJ, et al. Muscles Ligaments Tendons J. 2016;6(1):16–25.
  12. Schlegel TF, et al. J Shoulder Elbow Surg. 2021;30(8);1938–1948.
  13. Van Kampen C, et al. Muscles Ligaments Tendons J. 2013;3(3):229–235.
  14. Arnoczky SP, et al. Arthroscopy. 2017;33(2):278–283.

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