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Tips and Tricks for Augmenting Rotator Cuff Repair With a Bio-inductive Collagen Implant.

ABSTRACT: The contemporary literature suggests that a primary feature of recurrence of rotator cuff tear after arthroscopic repair is failure of tendon healing, which can occur for multiple reasons, including compromised tissue quality. Recently, the use of augmentation implants, grafts, or scaffolds has emerged as a strategy to address the issue of deficient rotator cuff tissue. A resorbable bio-inductive collagen implant (REGENETEN; Smith & Nephew, Andover, MA) has been shown to increase tendon thickness when applied in rotator cuff repair. This article presents an experienced surgeon's tips for implanting this device. In addition, we review the current literature about this bio-inductive implant.

SUBMITTER: Pupa L

PROVIDER: S-EPMC8719111 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Tips and Tricks for Augmenting Rotator Cuff Repair With a Bio-inductive Collagen Implant.

Pupa Lauren L Sheth Mihir M Goldenberg Neal N Shybut Theodore T

Arthroscopy techniques 20211109 12

The contemporary literature suggests that a primary feature of recurrence of rotator cuff tear after arthroscopic repair is failure of tendon healing, which can occur for multiple reasons, including compromised tissue quality. Recently, the use of augmentation implants, grafts, or scaffolds has emerged as a strategy to address the issue of deficient rotator cuff tissue. A resorbable bio-inductive collagen implant (REGENETEN; Smith & Nephew, Andover, MA) has been shown to increase tendon thicknes ...[more]

PMID: 35004146

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Project description:BackgroundRotator Cuff (RC) tendon tearing is a common clinical problem and there is a high incidence of revision surgery due to re-tearing. In an effort to improve patient outcome and reduce surgical revision, scaffolds have been widely used for augmentation of RC repairs. However, little is known about how scaffolds support tendon stem cell growth or facilitate tendon regeneration. The purpose of this study is to evaluate the structural and biological properties of a bioactive collagen scaffold (BCS) with the potential to promote tendon repair. Additionally, we conducted a pilot clinical study to assess the safety and feasibility of using the BCS for repair of RC tears.MethodsA series of physical, ultrastructural, molecular and in vitro tests determined the biocompatibility and teno-inductive properties of this BCS. In addition, a prospective case study of 18 patients with RC tendon tears (>20 mm in diameter) was performed in an open-label, single-arm study, involving either mini-open or arthroscopic surgical RC repair with the BCS. Clinical assessment of RC repair status was undertaken by MRI-imaging at baseline, 6 and 12 months and patient evaluated questionnaires were taken at baseline as well as 3, 6 & 12 months.ResultsThe BCS consists of highly purified type-I collagen, in bundles of varying diameter, arranged in a higher order tri-laminar structure. BCS have minimal immunogenicity, being cell and essentially DNA-free as well as uniformly negative for the porcine α-Gal protein. BCS seeded with human primary tendon-derived cells and exposed to 6% uniaxial loading conditions in vitro, supported increased levels of growth and proliferation as well as up-regulating expression of tenocyte differentiation marker genes including TNMD, Ten-C, Mohawk and Collagen-1α1. To test the safety and feasibility of using the BCS for augmentation of RC repairs, we followed the IDEAL framework and conducted a first, open-label single arm prospective case series study of 18 patients. One patient was withdrawn from the study at 3 months due to wound infection unrelated to the BCS. The remaining 17 cases showed that the BCS is safe to be implanted. The patients reported encouraging improvements in functional outcomes (ASES, OSS and Constant-Murley scores), as well as quality of life assessments (AQoL) and a reduction in VAS pain scores. MRI assessment at 12 months revealed complete healing in 64.8% patients (11/17), 3 partial thickness re-tears (17.6%) and 3 full thickness re-tears (17.6%).ConclusionThe BCS is composed of type-I collagen that is free of immunogenic proteins and supports tendon-derived cell growth under mechanical loading in vitro. This pilot study shows that it is safe and feasible to use BCS for RC argumentation and further controlled prospective studies are required to demonstrate its efficacy.The translational potential of this articleThe results of this study indicate that this bioactive collagen scaffold has unique properties for supporting tendon growth and that it is non-immunogenic. The clinical study further confirms that the scaffold is a promising biological device for augment of human rotator cuff repairs.

Project description:Purpose To compare patient-reported and surgical outcome measures in patients with and without secondary shoulder stiffness (SSS) undergoing rotator cuff repair (RCR). Methods Patients undergoing rotator cuff repair from 2014 to 2020 with complete patient-reported outcome measures (PROMs) by the short-form 12 survey (SF-12) were retrospectively reviewed to identify if operative intervention for SSS was performed alongside the RCR. Those patients with operative intervention for SSS were propensity matched to a group without prior intervention for stiffness by age, sex, laterality, body mass index, diabetes mellitus status, and the presence of a thyroid disorder. The groups were compared by rotator cuff tear (RCT) size, surgical outcomes, further surgical intervention, rotator cuff retear rate, postoperative range of motion (ROM), and SF-12 results at 1 year after surgery. Delta values were calculated for component scores of the SF-12 and ROM values by subtracting the preoperative result from the postoperative result. Results A total of 89 patients with SSS were compared to 156 patients in the control group at final analysis. The patients in the SSS group experienced a significant improvement in the delta mental health component score (MCS-12) of the SF-12 survey that was not seen in the control group (P = .005 to P = .539). Both groups experienced significant improvement by the delta physical health component score (PCS-12) of the SF-12 survey (SSS: 7.68; P < .001; control: 6.95; P < .001). The SSS group also experienced greater improvement of their forward flexion (25.8° vs 12.9°; P = .005) and external rotation (7.13° vs 1.65°; P = .031) ROM than the control group. Conclusions Operative intervention of SSS at the time of RCR has equivalent postoperative SF-12 survey outcome scores when compared to patients undergoing RCR without preoperative stiffness despite those patients having lower preoperative scores. Level of Evidence Level III retrospective comparative study.

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Tips and Tricks for Augmenting Rotator Cuff Repair With a Bio-inductive Collagen Implant.

Publications

Tips and Tricks for Augmenting Rotator Cuff Repair With a Bio-inductive Collagen Implant.

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