1. Prospective randomized controlled trial for patch augmentation in rotator cuff repair: 24-month outcomes.
- Author
-
Avanzi P, Giudici LD, Capone A, Cardoni G, Lunardi G, Foti G, and Zorzi C
- Subjects
- Acromion diagnostic imaging, Aged, Animals, Arthroscopy, Double-Blind Method, Female, Follow-Up Studies, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Prospective Studies, Reoperation, Rotator Cuff Injuries diagnostic imaging, Swine, Treatment Outcome, Visual Analog Scale, Rotator Cuff Injuries physiopathology, Rotator Cuff Injuries surgery, Skin Transplantation, Wound Healing
- Abstract
Background: To evaluate the anatomic integrity of rotator cuff repair performed by medialized single row and augmented by a porcine dermal patch, in comparison with a nonaugmented group., Methods: We conducted a single-center, prospective, double-blinded, randomized controlled trial. The sample size was predefined, and patients were divided into a study group and a control group, assessed preoperatively and at 1, 3, 6, 12, and 24 months. The EuroQol-visual analog scale; Constant-Murley questionnaire; Disabilities of the Arm, Shoulder and Hand Score; and Simple Shoulder Test were administered. The humeral-acromial distance was calculated on radiographs. Tendon thickness, tear extension, and tendon signal intensity were all measured on magnetic resonance images (MRIs) along with an evaluation of footprint extension and a classification into one of 4 healing grades-healed, thinned, partially healed, not healed., Results: The study population consisted of 92 patients who were equally randomized into 2 homogenous groups. Sixty-nine patients completed the 24-month follow-up. The study group showed a healing rate of 97.6% compared with 59.5% for the standard repair group. The study group showed better results in terms of repaired tendon thickness and footprint coverage, with a P value < .05, although the tendon density was comparable. The study group showed better strength recovery and functionality with the outcome scores submitted. During the entire study, only 2 patients reported complications, calling for a biopsy during revision surgery., Conclusions: Rotator cuff repairs augmented with a porcine dermal patch resulted in excellent clinical outcomes with a higher healing rate and close-to-normal MRI findings. The technique is safe and effective; in addition, it is reproducible and allows for better outcomes compared with those of standard medialized single-row repairs., (Copyright © 2019 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
- Full Text
- View/download PDF