BACKGROUND: Full-thickness rotator cuff tears (FTRCTs) represent a common shoulder injury that, if untreated, can progress in size, become increasingly painful, and inhibit function. These lesions are often surgically repaired, with double-row arthroscopic repair often preferred for larger tears. Biological augmentation technologies have been developed to improve rates of postoperative radiographic re-tear and enhance patient-reported outcomes after surgical FTRCT repair. This study sought to confirm that augmented repair with a bioinductive bovine collagen implant results in favorable re-tear rates and patient outcomes with follow-up to 2 years.
METHODS: A prospective multicenter cohort study was undertaken to determine the efficacy and safety of augmenting single- or double-row arthroscopic repair of FTRCTs with a bioinductive bovine collagen implant. Of 115 adult patients participating, 66 (57.4%) had medium (1-3 cm) tears and 49 (42.6%) had large (3-5 cm) tears. Magnetic resonance imaging and patient-reported outcomes (Shoulder and Elbow Surgeons [ASES] Shoulder Score and Constant-Murley Score [CMS]) were performed and recorded at baseline, 3 months, 1 year, and 2 years.
RESULTS: Mean duration of follow-up was 2.1 years (range, 1.5-2.9 years). Between baseline and 2-year follow-up, mean total thickness of the supraspinatus tendon increased by 12.5% for medium tears and by 17.1% for large tears. Radiographic re-tear was noted in 7/61 available patients (11.5%) with medium tears, and in 14/40 patients (35.0%) with large tears. In both groups, these tears primarily occurred before the 3-month follow-up visit (13/21 [61.9%]). Radiographic re-tear with the supplemented double-row (DR) repair technique was 13.2% overall (12/91 DR patients; 11.3% for medium tears and 15.8% for large tears). The minimal clinically important difference (MCID) was achieved by >90% of patients with both medium and large tears for both ASES and CMS. There were 2 serious adverse events classified by the treating surgeon as being possibly related to the device and/or procedure (1 case of swelling/drainage and 1 case of intermittent pain). Nine patients (7.8%; 4 medium tears and 5 large tears) required reoperation of the index rotator cuff surgery.
CONCLUSIONS: Final 2-year data from this study confirm that using this implant in augmentation of arthroscopic double-row repair of FTRCTs provides favorable rates of radiographic re-tear and substantial functional recovery. The relative safety of the device is also further supported.

UNASSIGNED: Biologic technologies can potentially augment existing arthroscopic rotator cuff repair to improve retear rates and postoperative outcomes. The purpose of this study was to evaluate healing rates and clinical outcomes of full-thickness rotator cuff repairs augmented with a bioinductive bovine collagen implant.
UNASSIGNED: In this prospective multicenter study, investigators enrolled 115 patients (mean age, 60.4 years) with full-thickness rotator cuff tears. There were 66 (57.4%) medium (1-3 cm) tears and 49 (42.6%) large (3-5 cm) tears. Eligible patients consisted of those ≥21 years of age with chronic shoulder pain lasting longer than 3 months and unresponsive to conservative therapy. Patients underwent single- or double-row repair augmented with a bioinductive bovine collagen implant. At the baseline, 3 months, and 1 year, magnetic resonance imaging was performed and patients were assessed for American Shoulder and Elbow Surgeons (ASES) Shoulder Score and Constant-Murley Score (CMS). The primary failure end point was retear, classified as any new full-thickness defect observed on magnetic resonance imaging.
UNASSIGNED: There were 13 retears (11.3%) at 3 months, with an additional 6 (19 total [16.5%]) found at 1 year. In large tears, double-row repair had a significantly lower rate of retear at 3 months (P = .0004) and 1 year (P = .0001) compared with single-row repair. ASES and CMS scores significantly improved between the baseline and 1 year for medium and large tears. At 1 year, the minimally clinically important difference for ASES and CMS was met by 91.7% (95% CI: 84.9-96.1) and 86.4% (95% CI: 78.2-92.4) of patients, respectively. Patients without retear and those <65 years of age had significantly better CMS scores at 1 year when compared with those with retear and those ≥65 years (P < .05). There was no statistically significant difference in outcomes based on treatment of the biceps tendon. Of 9 reported reoperations in the operative shoulder, only 2 were considered potentially related to the collagen implant.
UNASSIGNED: Interim results from this prospective study indicate a favorable rate of retear relative to the literature and improvement in clinical function at 1 year after adjunctive treatment with the study implant augmenting standard arthroscopic repair techniques.

BACKGROUND: Results on the effectiveness of PRP supplementation in arthroscopic rotator cuff repair are conflicting, making it difficult to draw definitive conclusions.
METHODS: This was a prospective, randomized, and double-blind study with two groups of 20 patients each (PRP group and control group). Degenerative supraspinatus full-thickness tears grade C2-C3 were subjected to arthroscopic repair; PRP supplementation was given to patients in the PRP group. The outcomes were assessed by DASH, Constant scales, and ultrasound before and 6 months after surgery. Pain measured by VAS was evaluated preoperatively and 7 and 30 days after surgery.
RESULTS: The two groups did not differ significantly by age, sex, and dominance of the affected side. In all surgical procedures, a long head of the biceps tenotomy and single-row repair were performed. The preoperative VAS was 5.6 ± 2.4 in PRP group and 6.4 ± 1.5 in the control group (p > 0.05). The group supplemented with PRP reported a VAS significantly better in the first week (2.5 ± 1.9 vs 5.3 ± 2.1, p < 0.05) and during the first month after surgery (1.5 ± 1.0 vs 3.2 ± 1.7, p < 0.05) compared to the control group. The preoperative Constant and DASH scores were 39.95 ± 12 and 51 ± 15.2, respectively, in the PRP group and 41 ± 11 (p > 0.05) and 45 ± 12.6 (p > 0.05) in the control group. The average Constant score improved significantly after 6 months to 81 ± 11.2 (p < 0.05) in the PRP group and 78.5 ± 9 (p < 0.05) in the control group. No differences were noted between the two groups (p > 0.05). The DASH score after 6 months was 17.4 ± 8 (p < 0.05) for the treatment group (the PRP group) and 21 ± 8.4 (p < 0.05) for the control group. No statistically significant differences were found as regards the DASH score in the two groups after 6 months (p > 0.05). The two groups showed no differences in the ultrasound evaluation after 6 months either. No re-ruptures occurred in either group.
CONCLUSIONS: PRP leads to a reduction in pain during a short-term follow-up. Pain reduction allows for a more rapid recovery of mobilization and improvement in functionality.
METHODS: Randomized controlled trial, Level of evidence, 1.