Most rotator cuff failures occur within the first 6 months post-operatively. This is well noted in research and literature on rotator cuff repairs:
Suture Fixation Provides Order of Magnitude Strength Improvement Over Tendon Staple Fixation, Enabling BioBrace® Load Sharing
- Published: 6/26/2025
- 5 min
"Since about 80% of the tendon retraction occurs in the first 12 weeks after surgery, these data also suggest that repairs should be protected in the early postoperative period, and repair strategies should endeavor to mechanically augment and improve the rate and quality of the repair in this critical early period."
- McCarron et al 2013. AJSM1.
"Thirteen (61.9%) of the radiographic retears noted in this cohort occurred in the immediate postoperative period leading up to the 3-month follow-up visit... Therefore, the timing of radiographic retears in the current analysis seems to indicate that the key contributor to failure in most cases was a failure to achieve adequate mechanical fixation during arthroscopic repair."
- Bushnell et al 2022. JSES2.
"Retears primarily occur between six and twenty-six weeks after arthroscopic rotator cuff repair, and few additional tears occur thereafter."
- Iannotti et al 2013. JBJS3.
Thus, reinforcing and protecting rotator cuff repairs in the early post-operative period may prevent early post-operative failure of the repairs observed in the literature.
Augmentation of a rotator cuff repair can be performed with certain implants to reinforce rotator cuff repairs at time zero. Adding a reinforced implant on top of a rotator cuff repair can reduce the possibility of suture pulling through the tendon by increasing the strength of the suture-tendon interface. Augmentation devices such as these are traditionally fixated to tendon tissue with suture, as this enables the device to impart its full strength onto the repair construct.
Certain augmentation devices such as Regeneten utilize plastic tendon anchors (commonly referred to as staples) to fixate the implant to the rotator cuff tendon. To date, however, there is no published data on the strength of these staples relative to suture.
Thus, tensile testing was performed to compare the pull-through strength (max load) of Regeneten Tendon Anchors (staples) to standard mattress stitches with #2 suture in a clinically relevant direction of loading (shear loading). It was hypothesized that suture would have a higher pull-through strength compared to the plastic staples.
Twelve mattress stitches and twelve staples were tested in rotator cuff tendon. Each fixation method was pulled perpendicular to the tendon to simulate pull-through of the fixation when in the tendon. Mattress stitches on average had a max load of 101.8 ± 41.5 N compared to plastic tendon anchors with a max load of 9.6 ± 2.8 N. This indicates mattress stitches to have over a 10x increase in strength compared to tendon anchors. All mattress sutures failed via pull through of the tendon. Six tendon anchors failed from pulling through the tendon, and six tendon anchors failed from breaking in half4.
Figure 1: Comparison of max load (N) between #2 suture mattress stitches and staples.
This test concludes that standard #2 suture fixation using mattress stitches in soft tissue is significantly stronger than plastic staples. In order to get the same fixation strength as a single #2 suture mattress stitch, 10 staples would need to be deployed. Staples are acceptable for augments such as Regeneten. Since the augments are not designed to add strength to a repair the staples do not need to do more than keep the augment fixated to the tendon. For a reinforced bioinductive implant such as BioBrace®, the additional strength of mattress stitches allows the augment to provide mechanical strength at time-zero and throughout the healing process. This means the augment adds supplemental strength to a rotator cuff repair.
This testing was expanded from one singular point of fixation in the tendon to a full thickness rotator cuff repair. The additional strength that suture fixation and BioBrace® provides to a rotator cuff repair was demonstrated in a full ovine rotator cuff model, where BioBrace® was shown to load share with the rotator cuff. This is described below.
BioBrace® was used to augment six double row and six single row rotator cuff repairs using mattress stitches, and was tested against double row and single row rotator cuff repairs without BioBrace®. BioBrace® was demonstrated to reinforce and add strength to both double row and single row rotator cuff repairs at time zero. Adding BioBrace® to the repairs with mattress stitches the increased max load of a standard double row repair +23%, and increased max load of a standard single row repair +33%. This means the addition of BioBrace® increased the amount of load required for failure to occur at the suture-tendon interface5.
BioBrace® increases the strength of rotator cuff repairs through load sharing. Since BioBrace® is also a bioinductive scaffold, it facilitates rapid new tissue growth, increasing tissue thickness over time6. The scaffold full of new tissue will impart mechanical loads on that tissue during the healing process, helping to regularly orient the tissue. Both reinforcement and facilitating new tissue growth are critical for preventing early post-operative failure of rotator cuff repairs. Finally, BioBrace® is fully bioresorbable, and will provide strength for 2 years before transitioning to tissue7. Early post-operative results of BioBrace® have been promising, with reported healing rates of 94% for high-risk rotator cuff patients8. This demonstrates the clinical value proposition of BioBrace® providing both strength and facilitating biology, and how this translates into positive outcomes for patients.
Figure 2: Comparison of max load (N) between BioBrace® augmented rotator cuff repairs and repairs alone.
1 McCarron JA, Derwin KA, Bey MJ, et al. Failure with continuity in rotator cuff repair "healing". Am J Sports Med. 2013;41(1):134-141.
2 Bushnell BD, Connor PM, 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 multicenter study. J Shoulder Elbow Surg. 2022;31(12):2532-2541.
3 Iannotti JP, Deutsch A, Green A, et al. Time to failure after rotator cuff repair: a prospective imaging study. J Bone Joint Surg Am. 2013;95(11):965-971.
4 Test Report Data on File. ConMed Corp. 2025.
5 Walsh, W.R. , Lovric, V, Crowley Rocco K, Batista J, Viswanathan G, Ott JM. 2024. “Mechanical Properties of Augmented Rotator Cuff Repairs Using an Ovine Infraspinatus Model” Presented at the American Academy of Orthopaedic Surgeons (AAOS) 2024 Annual Meeting; February 12-16, 2024, Conference.
6 Walsh, W.R. , Carter, A.J., Lovric V, Crowley J, Wills D, Wang T, Kanski G, Stanton R, Arnoczky S, Arciero R. 2021. “Tissue-Engineered Augmentation of A Rotator Cuff Tendon Using A Novel Bio-Inductive Biocomposite Scaffold: A Preliminary Study In Sheep” Presented at the Orthopaedic Research Society (ORS) 2021 Annual Meeting; February 12-16, 2021, Virtual.
7 Carter, A.J., V. Lovric, P. Morberg, J. Ott, J. Bendigo, J. Komenda, M. Aronson, K. Rocco, S. Arnoczky, and W.R. Walsh. 2021. “Characterization of a Novel Bio-Inductive Biocomposite Scaffold for Tendon and Ligament Healing.” Presented at the Orthopaedic Research Society (ORS) 2021 Annual Meeting; February 12-16, 2021, Virtual.
8 McMillan, Sean et al. “Favorable Early Patient-Reported Outcome Measures and Clinical Retear Rates in High-Risk Rotator Cuff Repairs Augmented with a Reinforced Bio-Inductive Implant at One-Year Follow Up.” Surgical technology international, vol. 45 sti45/1819. 16 Oct. 2024