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

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 gradesdhealed, 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. This study was approved by the Comitato Etico della Provincia di Verona (study no. 394 CEP).

Use of implantable meshes for augmented rotator cuff repair: a systematic review and meta-analysis

“…When compared with standard repair, two RCTs investigating porcine SIS xenograft (Restore) found no difference in the physical or mental components of SF-36. 35 39 Similarly, an RCT (Avanzi et al ) 37 and an observational comparative study (Flury et al ) 41 assessing different DXs did not find an improved EQ-5D at 2-year follow-up. Conversely, a comparative study using human allograft (Athroflex) reported a significant improvement in all components of SF-12 at 6 months and 2 years postoperatively (though not at 3 months).…”

“…The majority of studies (72%) undertook postoperative imaging after 1–2 years but with considerable heterogeneity existing in the radiological classification of re-tears and with seven studies 30 32 33 38 40 42 46 not providing any details. While the RCTs investigating human allograft (Graftjacket), 36 DX (Conexa) 37 and an unspecified collagen patch, 38 each demonstrated a significantly lower failure rate in the augmentation arm, neither of the RCTs investigating the small-intestine submucosa xenograft patch (Restore) 35 39 found any reduction in re-tear rate. In conflict with these findings, a multipatch comparative study 29 found no difference in failure rate between xenograft (Restore) and two different patches; human allograft (Graftjacket) or synthetic (Artelon).…”

“…Among RCTs, only one study found a sustained, statistically meaningful improvement in ASES and Constant Scores, but not UCLA Scale, 2 years after implantation of an allograft patch ( online supplemental table 4 ). 36 A further two studies, investigating a dermal xenograft (DX) 37 and an unspecified non-proprietary patch, 38 reported initial improvements in Constant Scores at 12 months, but this was not sustained at longer (2 years) follow-up. The two RCTs investigating decellularised porcine small intestine submucosa (Restore) 35 39 failed to demonstrate an improvement in patient-reported outcomes at 1–2 years follow-up, while the study by Leuzinger et al 29 only undertook intragroup comparisons between preoperative and postoperative Constant Scores, reporting similar improvements following implantation of an allograft, xenograft or synthetic patch.…”

A Historical Analysis of Randomized Controlled Trials in Rotator Cuff Tears

“…A total of 97 (53%) of 183 studies had a level of evidence I and 86 (47%) of 183 studies had a level of evidence II, according to the Oxford Center of EBM. A total of 170 (93%) of the 183 studies were single-centered [ 3 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 32 , 33 , 34 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 59 , 60 , 61 , 62 , 63 , 64 , 65 <...>…”

Healing and Functional Results of Dermal Allograft Augmentation of Complex and Revision Rotator Cuff Repairs

“…The data regarding their efficacy are variable, with retear rates reported as low as 2.4% and as high as 84%. 2,12 Use of grafts adds technical complexity, surgical time, and cost. The purpose of this study was to examine clinical outcomes and healing rates in complex and revision rotator cuff repairs with dermal allograft augmentation.…”