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Study: Bio-inductive collagen scaffold patch improves healing rates of large, massive rotator cuff repairs
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SAN DIEGO — Use of a bio-inductive collagen scaffold patch may improve healing rates of large and massive rotator cuff repairs as new tendon formation was shown on ultrasound and MRI, according to data presented at the American Orthopaedic Society for Sports Medicine Annual Meeting.
“This patch should be considered at least safe and effective, and it may show promise in improving the union rates of these large and massive tears. However, more work is needed to establish clear indications as no randomized trials have been undertaken yet,” Stephen Thon, MD, said.
In the prospective, proof-of-principle study, Thon and colleagues enrolled patients during 18 consecutive months. Overall, they studied 23 patients who underwent repair of large or massive rotator cuff tears augmented with a bio-inductive collagen patch. The bio-inductive collagen scaffold patch has highly porous type 1 bovine collagen and is designed to induce remodeling and revascularization at the site of tendon repair, he said.
The mean patient age was 58 years. Eleven patients had large rotator cuff tears and 12 patients had massive rotator cuff tears. Overall, 16 patients had previous failed rotator cuff repairs. Minimum follow-up was 2 years. Researchers obtained postoperative ultrasound to assess tendon thickness at 3, 6, 12 and 24 months, and MRIs confirmed healing and tendon thickness at least 6 months postoperatively. Final outcome measures included healed tenon on ultrasound and MRI, final tendon thickness and final ASES scores. Researchers defined failure as failed tendon to heal, conversion to reserve shoulder arthroplasty or any complication due to the implant.
Thon said there was a 96% healing rate on ultrasound and MRI and the researchers considered 91% of patients to have had successful outcomes. Mean rotator cuff thickness was 7 mm on ultrasound and was 5 mm on MRI. There were no differences in final tendon thickness or repair type. No failures in the primary group and no adverse reactions to the patch were observed. – by Kristine Houck, MA, ELS
Reference:
Thon S, et al. Paper 126. Presented at: American Orthopaedic Society for Sports Medicine Annual Meeting; July 5-8, 2018; San Diego.
Disclosure: Thon reports no relevant financial disclosures.
Perspective
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John D. Kelly IV, MD
The paper by Thon and colleauges on the use of a bio-inductive collagen patch to supplement repair of large and massive rotator cuff tears from Tulane is indeed impressive when one considers that 16 of 23 cuff repairs were revision cases. The highly porous type 1 bovine collagen patch is designed to induce remodeling and revascularization at the site of tendon repair and resulted in a 91% healing rate when combined with the surgeon’s cuff repair. This is overwhelmingly favorable to prior studies.
The study was prospective and did follow patients for at least 2 years. However, there was no control group and patient-based evaluation scales were not provided. It would be helpful to the reader to discern if patient satisfaction correlated with healing, as we all know that “coverage” does not always translate to improved function. Furthermore, inclusion of Goutallier grade preoperatively will further help guide the reader to the applicability of this biologic adjunct.
A great difficulty in appreciating the value of the scaffold is that the surgeries were presumably performed by a master surgeon (FS) who skillfully employs the principles of adequate releases, margin convergence and secure, yet relatively tension-free, tendon fixation. It is hard to ascertain the effects of surgeon skill (who by the way, traditionally uses few anchors) from the scaffold.
With that being said, the authors are to be commended in showing that their approach to the large and massive cuff tear, even in the presence of revision surgery, will translate to superb healing rates as measured by MRI and ultrasound.
References:
Boileau P, et al. J Bone Joint Surg Am. 2005;87:1229-1240.
Galatz LM., et al. J Bone Joint Surg Am. 2004;86-A:219-224.
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