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      Evidence for Utilization of Injectable Biologic Augmentation in Primary Rotator Cuff Repair: A Systematic Review of Data From 2010 to 2022

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          Abstract

          Background:

          Biologic healing after rotator cuff repair remains a significant challenge. Injectable biologic augmentation may improve tissue quality at the suture-tendon interface.

          Purpose:

          To investigate the effect of injectable biologic supplementation in rotator cuff repair and to assess the quality and adherence to evolving reporting standards.

          Study Design:

          Systematic review; Level of evidence, 3.

          Methods:

          A systematic review was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Included were 40 studies: 29 preclinical (in vivo animal models) and 11 clinical. Each clinical study was assessed for quality, risk of bias, and adherence to relevant MIBO (Minimum Information for Studies Evaluating Biologics in Orthopaedics) guidelines. The outcomes of interest were reported load to failure, load to gap, gap size, and stiffness in the preclinical studies, and healing rate and any patient-reported outcome measures in the clinical studies.

          Results:

          Injectables reported included growth factors (eg, transforming growth factor–beta 3, erythropoietin), bone marrow–derived mesenchymal stem cells and adipose-derived mesenchymal stem cells (ADSCs), and other agents such as platelet-rich plasma (PRP) and hyaluronic acid. The most common findings for preclinical injectables were increased load to failure (16/29 studies; 55.2%) and improved collagen histological quality (11/29 studies; 37.9%). All 11 clinical studies (10 PRP, 1 ADSC) indicated no adverse events, with similar or improved patient-reported outcomes compared with repairs in the control groups. In 1 study utilizing an innovative delivery technique, a concentrated PRP globule with fibrin matrix was shuttled over a suture to maintain concentrated PRP at the repair site and demonstrated a significant decrease in retears ( P = .03) at a 31-month follow-up. A matched-cohort study investigating augmentation with ADSCs demonstrated a significantly lower retear rate in the ADSC-augmented group than the control group at a 28-month follow-up ( P < .001). On average, the clinical studies adhered to 66% of relevant MIBO reporting guidelines and had a low risk of bias.

          Conclusion:

          Approximately 83% of preclinical studies found a positive biomechanical or histological effect, with no studies showing an overall negative effect. Clinically, utilization of innovative delivery techniques may reduce the risk of arthroscopic washout of PRP and improve retear rates. ADSCs were shown to reduce retear rates at a 28-month follow-up.

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          Most cited references71

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          Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.

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            The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials

            Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurate
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              The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears.

              The impact of a recurrent defect on the outcome after rotator cuff repair has been controversial. The purpose of this study was to evaluate the functional and anatomic results after arthroscopic repair of large and massive rotator cuff tears with use of ultrasound as an imaging modality to determine the postoperative integrity of the repair. Eighteen patients who had complete arthroscopic repair of a tear measuring >2 cm in the transverse dimension were evaluated at a minimum of twelve months after surgery and again at two years after surgery. The evaluation consisted of a standardized history and physical examination as well as calculation of the preoperative and postoperative shoulder scores according to the system of the American Shoulder and Elbow Surgeons. The strength of both shoulders was quantitated postoperatively with use of a portable dynamometer. Ultrasound studies were performed with use of an established and validated protocol at a minimum of twelve months after surgery. Recurrent tears were seen in seventeen of the eighteen patients. Despite the absence of healing at twelve months after surgery, thirteen patients had an American Shoulder and Elbow Surgeons score of >/=90 points. Sixteen patients had an improvement in the functional outcome score, which increased from an average of 48.3 to 84.6 points. Sixteen patients had a decrease in pain, and twelve had no pain. Although eight patients had preoperative forward elevation to /=90 points, and six patients had a score of /=80.
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                Author and article information

                Journal
                Orthop J Sports Med
                Orthop J Sports Med
                OJS
                spojs
                Orthopaedic Journal of Sports Medicine
                SAGE Publications (Sage CA: Los Angeles, CA )
                2325-9671
                3 February 2023
                February 2023
                : 11
                : 2
                : 23259671221150037
                Affiliations
                []Albany Medical College, Albany, New York, USA.
                []Tufts University School of Medicine, Boston, Massachusetts, USA.
                [§ ]New England Baptist Hospital, Boston, Massachusetts, USA.
                []Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
                [5-23259671221150037] Investigation performed at New England Baptist Hospital, Boston, Massachusetts, USA
                Author notes
                [*] [* ]Olivia J. Bono, BA, Albany Medical College, 49 New Scotland Avenue, Albany, NY 12208, USA (email: oliviabono@ 123456gmail.com ).
                Article
                10.1177_23259671221150037
                10.1177/23259671221150037
                9900676
                0275f65c-a7bd-46a9-bb49-7a3280e2acca
                © The Author(s) 2023

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 License ( https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits non-commercial use, reproduction and distribution of the work as published without adaptation or alteration, without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 12 September 2022
                : 21 October 2022
                Categories
                Article
                Custom metadata
                ts3

                rotator cuff repair,augmentation,injectable biologics,platelet-rich plasma

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