Paolo Avanzi1, Luca Dei Giudici2, Antonio Capone3, Gaia Cardoni4, Gianluigi Lunardi5, Giovanni Foti6, Claudio Zorzi1. 1. Department of Orthopaedics, Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy. 2. Orthopaedic Unit, Casa di Cura "Villa Igea" Hospital, Ancona, Italy. 3. Department of Surgical Science, Orthopaedic Clinic, University of Cagliari, Ospedale Marino, Cagliari, Italy. 4. Department of Surgical Science, Orthopaedic Clinic, University of Cagliari, Ospedale Marino, Cagliari, Italy. Electronic address: gaia.cardoni@gmail.com. 5. Department of Medical Oncology, Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy. 6. Department of Radiology, Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy.
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.
RCT Entities:
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.
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