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      Preliminary Clinical Outcomes Following Biologic Augmentation of Arthroscopic Rotator Cuff Repair Using Subacromial Bursa, Concentrated Bone Marrow Aspirate, and Platelet-Rich Plasma

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          Abstract

          Purpose

          To evaluate the clinical outcomes of patients who underwent arthroscopic rotator cuff repair augmented using subacromial bursa, concentrated bone marrow aspirate (cBMA), and platelet-rich plasma.

          Methods

          Sixteen patients were included in the study who underwent arthroscopic rotator cuff repair augmented using subacromial bursa, cBMA, and platelet-rich plasma from January 2018 to July 2018 and had a minimum 1-year follow-up. American Shoulder and Elbow Surgeons (ASES), Simple Shoulder Test, Constant-Murley, and Single Assessment Numerical Evaluation (SANE) scores were collected preoperatively and at terminal follow-up. To determine the clinical relevance of ASES scores, the minimal clinically important difference, substantial clinical benefit, and the patient acceptable symptomatic state thresholds were used. In vitro cellular proliferation of subacromial bursa (nucleated cells/gram) and cBMA (nucleated cells and colony-forming units/cc) samples was evaluated and correlated to clinical outcomes scores.

          Results

          Mean follow-up was 12.6 ± 1.8 months (range 12-19 months). Patients achieved significant improvement in ASES (45.8±22.5 pre vs 88.5 ± 14.6 post, Δ44.7 ± 20.7; P = .001), Simple Shoulder Test (4.3 ± 3.2 pre vs 10.4 ± 1.6 post, Δ5.7 ± 3.9, P = .002), Constant-Murley (44.3 ± 18.2 pre vs 83.6 ± 17.5 post, Δ37.2 ± 21.8; P = .001), SANE (13.3 ± 10.7 pre vs 86.3 ± 17.5 post, Δ71.9 ± 22.9; P = .001), and pain scores (5.0±2.8 pre vs 1.1 ± 1.6 post, Δ3.5±2.5, P = .001) at final follow-up. With regards to ASES score, 93.8% of patients achieved the minimal clinically important difference, 93.8% the substantial clinical benefit, and 62.5% reached or exceeded the patient acceptable symptomatic state criteria. There was a significant positive correlation of nucleated cell count of cBMA with postoperative SANE score (r = 0.707; P = .015) and delta in ASES score (r = 0.727; P = .011). All other correlations were found to be nonsignificant ( P > .05, respectively).

          Conclusions

          Patients undergoing arthroscopic rotator cuff repair augmented using the Mega-Clot with bursa technique achieved significant improvement in functional outcomes at a minimum 1-year follow-up, with 93.8% of patients reaching substantial clinical benefit.

          Level of Evidence

          Level IV, therapeutic case series.

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          Most cited references53

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          Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement.

          The considerable therapeutic potential of human multipotent mesenchymal stromal cells (MSC) has generated markedly increasing interest in a wide variety of biomedical disciplines. However, investigators report studies of MSC using different methods of isolation and expansion, and different approaches to characterizing the cells. Thus it is increasingly difficult to compare and contrast study outcomes, which hinders progress in the field. To begin to address this issue, the Mesenchymal and Tissue Stem Cell Committee of the International Society for Cellular Therapy proposes minimal criteria to define human MSC. First, MSC must be plastic-adherent when maintained in standard culture conditions. Second, MSC must express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 or CD11b, CD79alpha or CD19 and HLA-DR surface molecules. Third, MSC must differentiate to osteoblasts, adipocytes and chondroblasts in vitro. While these criteria will probably require modification as new knowledge unfolds, we believe this minimal set of standard criteria will foster a more uniform characterization of MSC and facilitate the exchange of data among investigators.
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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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              A standardized method for the assessment of shoulder function.

              The American Shoulder and Elbow Surgeons have adopted a standardized form for assessment of the shoulder. The form has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain and instability and an activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. The patient can complete the self-evaluation portion of the questionnaire in the absence of a physician. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). It is hoped that adoption of this instrument to measure shoulder function will facilitate communication between investigators, stimulate multicenter studies, and encourage validity testing of this and other available instruments to measure shoulder function and outcome. Copyright © 1994 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.
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                Author and article information

                Contributors
                Journal
                Arthrosc Sports Med Rehabil
                Arthrosc Sports Med Rehabil
                Arthroscopy, Sports Medicine, and Rehabilitation
                Elsevier
                2666-061X
                05 October 2020
                December 2020
                05 October 2020
                : 2
                : 6
                : e803-e813
                Affiliations
                [a ]Department of Orthopaedic Surgery, UConn Health Center, Farmington, Connecticut, U.S.A.
                [b ]Department of Orthopaedic Sports Medicine, Technical University of Munich, Munich, Germany
                [c ]Department of Trauma, Orthopaedic, Plastic and Hand Surgery, University Hospital of Augsburg, Augsburg, Germany
                [d ]Department of Shoulder Surgery, ATOS Clinic, Cologne, Germany
                Author notes
                []Address correspondence to Lukas N. Muench, M.D., Department of Orthopaedic Surgery, UConn Health Center, Farmington CT, 06030. lukas.muench@ 123456tum.de
                Article
                S2666-061X(20)30100-0
                10.1016/j.asmr.2020.07.019
                7754610
                33376995
                5d34af66-7c26-4a8c-b236-5c2d6c72ec2a
                © 2020 by the Arthroscopy Association of North America. Published by Elsevier.

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 31 October 2019
                : 20 July 2020
                Categories
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