Prospective randomized controlled trial for patch augmentation in rotator cuff repair: 24-month outcomes

• Published in: Journal of shoulder and elbow surgery 2019-10, Vol.28 (10), p.1918-1927
• Main Authors: Avanzi, Paolo, Giudici, Luca dei, Capone, Antonio, Cardoni, Gaia, Lunardi, Gianluigi, Foti, Giovanni, Zorzi, Claudio
• Format: Article
• Language: English
• Subjects: Acromion - diagnostic imaging; Aged; Animals; Arthroscopy; Double-Blind Method; Female; Follow-Up Studies; Humans; Magnetic Resonance Imaging; Male; Middle Aged; porcine dermal patch; Prospective Studies; Reoperation; rotator cuff augmentation; Rotator Cuff Injuries - diagnostic imaging; Rotator Cuff Injuries - physiopathology; Rotator Cuff Injuries - surgery; Rotator cuff repair; shoulder arthroscopy; shoulder augmentation; shoulder controlled trial; Skin Transplantation; Swine; Treatment Outcome; Visual Analog Scale; Wound Healing
• ISSN: 1058-2746; 1532-6500
• DOI: 10.1016/j.jse.2019.05.043

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. 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. 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. 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.