Dataset Information

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry.

ABSTRACT:

Purpose

The purpose of this study was to prospectively collect safety and efficacy data in a large group of patients undergoing arthroscopic repair of full-thickness rotator cuff tears augmented with a resorbable bioinductive bovine collagen implant designed to promote healing.

Methods

Seventeen centers across the United States enrolled patients in an institutional review board-approved registry to collect outcomes data on the implant. Patients undergoing surgical management of full-thickness rotator cuff tears augmented with the implant were enrolled. Inclusion criteria were age of ≥21 years, willingness to participate and the ability to read and speak English. Exclusion criteria included hypersensitivity to bovine-derived products. Patients were assessed before and after surgery at up to 1 year with outcomes including the single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12) mental components and physical components (VR-12 PCS), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcome measures. Ad hoc analyses were performed to compare these outcomes at all time points depending on tear size (small/medium vs large/massive). Serious complications were collected.

Results

Of 210 patients enrolled, 192 had 1-year follow-up data available. The patients experienced statistically significant improvement between baseline and 1 year for mean SANE, VR-12 PCS, ASES, and WORC scores (40.0-82.0, 33.5-47.3, 46.2-87.8, and 36.2-81.0, respectively; P < .001 for all results). Ad-hoc analysis demonstrated that similar results were obtained at 1 year regardless of tear size. Twenty patients (10.4%) experienced serious complications (10.4%), including revision surgery (n = 18), proximal humerus fracture/partial subscapularis tear resulting from multiple falls (n = 1), and adhesive capsulitis (n = 1).

Conclusions

The safety and efficacy of a bioinductive implant in the surgical management of full-thickness rotator cuff tears at 1 year was shown in this study. Implant efficacy appears to be comparable regardless of the underlying tear size.

Level of evidence

Level IV, therapeutic case series.

SUBMITTER: McIntyre LF

PROVIDER: S-EPMC8527318 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry.

McIntyre Louis F LF McMillan Sean S Trenhaile Scott W SW Bishai Shariff K SK Bushnell Brandon D BD

Arthroscopy, sports medicine, and rehabilitation 20210820 5

<h4>Purpose</h4>The purpose of this study was to prospectively collect safety and efficacy data in a large group of patients undergoing arthroscopic repair of full-thickness rotator cuff tears augmented with a resorbable bioinductive bovine collagen implant designed to promote healing.<h4>Methods</h4>Seventeen centers across the United States enrolled patients in an institutional review board-approved registry to collect outcomes data on the implant. Patients undergoing surgical management of fu ...[more]

PMID: 34712984

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Project description:PurposeTo determine the likelihood of and risk factors for tear progression among patients with a symptomatic partial or full-thickness rotator cuff tears (RCTs) who return with continued shoulder pain and obtain subsequent magnetic resonance imaging (MRI) and to identify various patient factors and MRI findings associated with rotator cuff tear progression.MethodsWe performed a retrospective review of MRI studies from Veteran's Affair patients with conservatively treated partial- or full-thickness rotator cuff tears. Patient characteristics and demographics were obtained via chart review. Tear characteristics were measured on MRI obtained a minimum of 1 year apart. We defined progression as either (1) an increase from a partial to a full-thickness tear or (2) an increase in tear width or retraction of at least 5 mm. Statistical analysis using χ2, Fisher exact, Student t, and Mann-Whitney U test was then performed as appropriate, looking for factors involved in RCT progression.ResultsWe evaluated 412 MRI studies from 206 Veteran's Affair patients with conservatively treated partial- or full-thickness rotator cuff tears from October 1999 to March 2020. Overall, 61% of RCTs had progressed at a mean of 3.2 ± 2.3 years follow-up. Among all patients, 74% of full-thickness tears progressed in size, 42% of partial-thickness tears progressed in size, and 29% of partial-thickness tears progressed to full-thickness tears. On univariate analysis, full-thickness tears (P < .001), disruption of the anterior rotator cuff cable (P = .001), subscapularis involvement (P = .004), tear retraction (P < .001), and tear width (P < .001) all increased the likelihood of progression. On multivariate analysis, full-thickness tears (P < .001) and subscapularis involvement (P = .045) were correlated with progression.ConclusionsRCTs progress over time in terms of size of tear and from partial- to full-thickness tears. There is an increased risk of tear progression in patients with full-thickness tears when compared with partial-thickness tears along with subscapularis tear involvement. Rates of progression are larger than previously reported rates for both partial- and full-thickness tears, noting that our study population were those patients who continued to be symptomatic from their tears.Level of evidenceLevel IV, prognostic case series.

Project description:BACKGROUND: The single-row and double-row fixation techniques have been widely used for rotator cuff tears. However, whether the double-row technique produces superior clinical or anatomic outcomes is still considered controversial. This study aims to use meta-analysis to compare the clinical and anatomical outcomes between the two techniques. METHODS: The Pubmed, Embase, and Cochrane library databases were searched for relevant studies published before November 1, 2012. Studies clearly reporting a comparison of the single-row and double-row techniques were selected. The Constant, ASES, and UCLA scale systems and the rotator cuff integrity rate were evaluated. The weighted mean differences and relative risks were calculated using a fixed-effects or random-effects model. RESULTS: Eight studies were included in this meta-analysis. The weighted mean differences of the ASES (-0.84; P?=?0.04; I(2)?=?0%) and UCLA (-0.75; P?=?0.007; I(2)?=?0%) scales were significantly low in the single-row group for full-thickness rotator cuff tears. For tear sizes smaller than 3 cm, no significant difference was found between the groups no matter in Constant (P?=?0.95; I(2)?=?0%), ASES (P?=?0.77; I(2)?=?0%), or UCLA (P?=?0.24; I(2)?=?13%) scales. For tear sizes larger than 3 cm, the ASES (-1.95; P?=?0.001; I(2)?=?49%) and UCLA (-1.17; P?=?0.006; I(2)?=?0%) scales were markedly lower in the single-row group. The integrity of the rotator cuff (0.81; P?=?0.0004; I(2)?=?10%) was greater and the partial thickness retear rate (1.93; P?=?0.007; I(2)?=?10%) was less in the double-row group. Full-thickness retears showed no difference between the groups (P?=?0.15; I(2)?=?0%). CONCLUSION: The meta-analysis suggests that the double-row fixation technique increases post-operative rotator cuff integrity and improves the clinical outcomes, especially for full-thickness rotator cuff tears larger than 3 cm. For tear sizes smaller than 3 cm, there was no difference in the clinical outcomes between the two techniques. LEVEL OF EVIDENCE: Level I.

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Dataset Information

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry.

Purpose

Methods

Results

Conclusions

Level of evidence

Publications

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry.

Similar Datasets

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