Summary
Intraoperative amniotic suspension allograft injection did not provide significant amelioration to arthroscopic rotator cuff repair compared to the control group as no superiority seen in early functional recovery and tendon-healing. Only significantly better internal rotation was noted at 12 months postoperatively.
Abstract
Purpose
To evaluate the efficacy and safety of amniotic suspension allograft augmentation in arthroscopic repairs of small to large supraspinatus tears
Study Design
Prospective, double-blinded, randomized controlled trial; Level of evidence 1
Method
A total of 103 patients undergoing arthroscopic repairs for small to large supraspinatus tears were randomly assigned to either ASA-augmented repair (ASA group) or conventional repair (control group). Clinical outcomes were to be evaluated preoperatively as well as at postoperative 1, 3, 6, and 12 months. The primary outcome was the Constant-Murley score (CMS), secondary outcomes included the visual analog score (VAS) for pain, range of motion (ROM), functional outcomes (UCLA and ASES scores). MRI was evaluated at preoperatively and at postoperative 6 and 12 months for tendon healing status and re-tear rate.
Results
97 patients (47 in the ASA group and 50 in the control group) completed the minimum 12-month follow-up. Except for significantly better internal rotation at postoperative 12 months (reaching T7 level: 34% in ASA group versus 10% in the control group, P = 0.029), intraoperative amniotic suspension allograft augmentation demonstrated no superiority in early functional recovery, retear rate and tendon-healing, irrespective of tear size. For within-group comparison, both the ASA and control groups exhibited significant improvement in CMS and ROM at 6 and 12 months, but not at 3 months; for UCLA, ASES, and VAS scores, both groups showed significant improvement at all time points. The most substantial improvement in functional outcomes and range of motion following rotator cuff repair were observed at 3-6 months postoperatively, irrespective of ASA augmentation.
Conclusion
Intraoperative amniotic suspension allograft injection did not provide significant amelioration to arthroscopic rotator cuff repair compared to the control group as no superiority seen in early functional recovery and tendon-healing. Only significantly better internal rotation was noted at 12 months postoperatively.