Novel Augment Improves Strength and Reduces Creep at Time-Zero

2/6/2024

Repair of massive rotator cuff tears remains a challenging procedure with variable success. Retear rate of the primary surgical repair site for large and massive full-thickness rotator cuff tears ranges from 34% to 94%.1,2 Failure of the repair commonly occurs within the first six months post-operatively and is attributed to two main factors: insufficient biologic healing of the native tendon tissue and mechanical failure at the suture-tendon interface.3,4,5

Surgeons are constantly looking for ways to lower retear rates and improve patient outcomes. Augmentation of rotator cuff tears has quickly gained traction due to the potential to enhance the strength, healing, and clinical outcomes of the repair. 

Rotator cuff augmentation is often considered for patients with large to massive rotator cuff tears or for those patients deemed “higher risk” due to various comorbidities.6 Augmentation can provide mechanical stability, improve healing at the repair site, and in some cases, both.6

The materials used to augment these repairs are rapidly advancing, as is our knowledge of the performance and integration of these augments. 

A recent study investigated strength (i.e. max load) and cyclic creep in a rotator cuff repair with and without augmentation using a reinforced bioinductive implant at time zero in an ovine model.7 

Twelve ovine infraspinatus tendons were dissected down to simulate a full thickness rotator cuff tear. All repairs used the same single row technique, six were augmented with BioBrace® while the other six acted as the control group. BioBrace® was secured independent of the repair using free sutures medially and was secured laterally with bone anchors. All specimens were cyclically tested and pulled to failure.7

BioBrace® augmentation reduced cyclic creep by 23% compared to the non-augmented control (p-val<0.01). Augmentation with BioBrace® increased the max load of the repair by 114N, or 34%, compared to the non-augmented control group (p-val=0.03).7

Augmenting a rotator cuff repair with BioBrace® increased time-zero strength and reduced cyclic creep, as observed in an ovine model.7 This suggests that augmentation, as performed in this study, may alleviate stress from the tendon and potentially reduce failure rates of rotator cuff repair at the suture-tendon interface.

The two main factors that contribute to rotator cuff repair failure are poor healing and mechanical failure at the suture-tendon interface. This study shows that augmentation with a reinforced bioinductive implant can increase the repair strength and reduce cyclic creep.7 Additionally, BioBrace® has been shown to support new tissue ingrowth.8,9 BioBrace® addresses the two main causes of rotator cuff repair failure, and therefore has the potential to improve current repair techniques and patient outcomes.

To read the full study, click here.
To learn more about the BioBrace® Reinforced Bioinductive Implant, click here.

 

1Rashid, M, C Cooper, J Cook, D Cooper, S Dakin, S Snelling, and A Carr. “Increasing Age and Tear Size Reduce Rotator Cuff Repair Healing Rate at 1 Year.” Acta Orthopaedica 88, no. 6 (2017): 606–11. https://doi.org/10.10  80/17453674.2017.1370844.
2Neri, B, K Chan, and Y Kwon. “Management of Massive and Irreparable Rotator Cuff Tears.” Journal of Shoulder and Elbow Surgery 18, no. 5 (2009): 808–18. https://doi.org/10.1016/j.jse.2009.03.013.
3McCarron, J. A., Derwin, K. A., Bey, M. J., Polster, J. M., Schils, J. P., Ricchetti, E. T., & Iannotti, J. P. (2013). Failure with continuity in rotator cuff repair “healing”. The American journal of sports medicine, 41(1), 134–141. https://doi.org/10.1177/0363546512459477
4Iannotti, J. P., Deutsch, A., Green, A., Rudicel, S., Christensen, J., Marraffino, S., & Rodeo, S. (2013). Time to failure after rotator cuff repair: a prospective imaging study. The Journal of bone and joint surgery. American volume, 95(11), 965–971. https://doi.org/10.2106/JBJS.L.00708
5Ponce, B. A., Hosemann, C. D., Raghava, P., Tate, J. P., Sheppard, E. D., & Eberhardt, A. W. (2013). A biomechanical analysis of controllable intraoperative variables affecting the strength of rotator cuff repairs at the suture-tendon interface. The American journal of sports medicine, 41(10), 2256–2261. https://doi.org/10.1177/0363546513499228
6 Yanke A, Dandu N, Credille K, Damodar D, Wang Z, Cole BJ. Indications and Technique: Rotator Cuff Repair Augmentation. J Am Acad Orthop Surg. 2023 Dec 15;31(24):1205-1210. doi: 10.5435/JAAOS-D-23-00101. Epub 2023 Oct 10. PMID: 37816190.
7Department of Bioinductive Technologies. (2023) Rotator cuff repair augmented with a reinforced bioinductive implant improves strength and reduces creep at time-zero in an ovine model. [white paper]. CONMED. https://www.conmed.com/-/media/conmed/documents/clinical/ortho_biobrace_rotatorcuff_wp.ashx
8Carter, AJ, V Lovric, P Morberg, J Ott, J Bendigo, J Komenda, M Aronson, K Rocco, S Arnoczky, and WR Walsh. 2021. “Characterization of a Novel BioInductive Biocomposite Scaffold for Tendon and Ligament Healing.” Presented at the Orthopaedic Research Society (ORS) 2021 Annual Meeting; February 12-16, 2021, Virtual.
9Walsh, WR, AJ Carter, V Lovric, J Crowley, D Wills, T Wang, G Kanski, R Stanton, S Arnoczky, and R Arciero. 2021. “TissueEngineered 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.