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. 2022 May 13;10(5):23259671221094848.
doi: 10.1177/23259671221094848. eCollection 2022 May.

Use of a Nanofiber Resorbable Scaffold During Rotator Cuff Repair: Surgical Technique and Results After Repair of Small- to Medium-Sized Tears

Affiliations

Use of a Nanofiber Resorbable Scaffold During Rotator Cuff Repair: Surgical Technique and Results After Repair of Small- to Medium-Sized Tears

Abhijit Seetharam et al. Orthop J Sports Med. .

Abstract

Background: The rate of retear after primary rotator cuff failure remains unacceptably high (up to 36% for small- to medium-sized tears). Augmentation of cuff repair with scaffold devices has been reported to improve healing after cuff repair.

Purpose/hypothesis: To describe the surgical technique of using an interpositional nanofiber scaffold during rotator cuff repair and report on a retrospective series of patients regarding functional outcomes and postoperative healing on magnetic resonance imaging (MRI). We hypothesized that augmentation of cuff repair with an interpositional scaffold would result in a high rate of tendon healing and excellent functional outcomes.

Study design: Case series; Level of evidence, 4.

Methods: A total of 33 patients underwent arthroscopic rotator cuff repair augmented with a nanofiber, bioresorbable polymer patch secured as an inlay between the tendon and underlying bone. Patients were evaluated preoperatively and postoperatively with the Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons (ASES) shoulder score, and active range of motion (ROM) measurements. Postoperative MRI was used to evaluate repair status.

Results: At a minimum follow-up of 6 months, the patients showed significant improvement on SST and ASES scores (P < .0001 for both). ROM in forward flexion, abduction, internal rotation, and external rotation significantly improved at 6 months postoperatively (P < .05 for all). MRI at an average of 11 months postoperatively showed healing in 91% of patients; one patient had a recurrent tear with transtendon failure, and another patient had retear at the insertional site. The patch was not visible on postoperative imaging, suggesting complete resorption in all patients. No adverse events were associated with the patch.

Conclusion: Our results demonstrate the preliminary safety and efficacy of a novel, bioresorbable synthetic scaffold for rotator cuff repair. The use of the scaffold resulted in a 91% tendon healing rate and significant improvements in functional and patient-reported outcome measures. The results are promising for improving the current unacceptably high rate of rotator cuff repair failure.

Keywords: biological healing enhancement; rotator cuff; shoulder; tissue engineering.

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Conflict of interest statement

One or more of the authors has declared the following potential conflict of interest or source of funding: Funding for the postoperative MRI was provided by Atreon Medical. B.L.B. has received education payments from Crossroad Orthopedics; consulting fees from CTM Medical, DePuy Synthes, DJO, Encore Medical, and Stryker; nonconsulting fees from Arthrex and The Progressive Orthopaedic Company; royalties from DJO; and hospitality payments from Medical Device Business Services. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.

Figures

Figure 1.
Figure 1.
Nanofiber scaffold before insertion during rotator cuff repair.
Figure 2.
Figure 2.
Intraoperative preparation and insertion of the scaffold. (A) The scaffold is inserted onto the suture of a medial row anchor. (B) The scaffold is advanced using the medial row anchor suture. (C) Before insertion through the cannula, the scaffold is folded in half before being unfolded and placed between the bone and tendon.
Figure 3.
Figure 3.
Flowchart of the patient selection process. RTC, rotator cuff repair.
Figure 4.
Figure 4.
Comparison of preoperative and postoperative active shoulder range of motion. *P < .01. **P < .001.
Figure 5.
Figure 5.
Comparison of preoperative and postoperative American Shoulder and Elbow Surgeons (ASES) and Simple Shoulder Test (SST) scores. Error bars represent standard deviations. ***P < .00001.
Figure 6.
Figure 6.
(A) Postoperative MRI demonstrating successful supraspinatus tendon repair without evidence of retear. (B) The nanofiber scaffold was not visible, suggesting complete resorption.

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