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      Subacromial spacer implantation for massive rotator cuff tears : Clinical outcome of arthroscopically treated patients Translated title: Implantation eines subakromialen Platzhalters bei Rotatorenmanschettenmassenruptur : Klinisches Ergebnis arthroskopisch versorgter Patienten

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          Abstract

          Background

          Massive rotator cuff tears (MRCT) can be treated arthroscopically by partial reconstruction, tenotomy/tenodesis of the long head of the biceps, and debridement. A new treatment option is the additional implantation of a biodegradable spacer (InSpace Balloon®; ISB) into the subacromial space, which reduces subacromial shear forces to keep the humeral head centered in the glenoid. The aim of this study is to investigate the clinical outcome of patients with MRCT who were treated arthroscopically with or without an additional ISB.

          Methods

          The clinical outcome of patients treated with conventional arthroscopic techniques ( n = 11, group A, partial repair, biceps tenotomy, and debridement) and that of patients treated with a supplementary ISB ( n = 12, group B) was retrospectively analyzed. Preoperatively and postoperatively, shoulder function was assessed with the Constant and American Shoulder and Elbow Surgeons (ASES) scores. At follow-up after a mean of 22 months, patients filled out a questionnaire about their subjective satisfaction.

          Results

          Preoperative shoulder function was lower in patients treated with an ISB (ASES score: group A, 59.1; group B, 31.5; Constant score: group A, 60.7; group B, 36.8). At follow-up, both groups had improved shoulder function (Constant score: group A, 60.7–77.6; p < 0.001; group B, 36.8–69.5; p < 0.001; ASES score: group A, 59.1–88.6; p < 0.001; group B, 31.5–85.7; p < 0.001). Patients in both groups were subjectively satisfied with their outcome.

          Conclusion

          The ISB is a feasible treatment option for MRCT, providing subjective pain relief and improved shoulder function. Further studies with larger patient collectives and longer follow-up are needed to confirm whether it is a safe and cost-effective treatment.

          Zusammenfassung

          Hintergrund

          Rotatorenmanschettenmassenrupturen (MRCT) können arthroskopisch durch Partialrekonstruktion, Bizepssehnentenodese- oder -tenotomie und ein Débridement therapiert werden. Eine neue Behandlungsform stellt die zusätzliche Implantation eines resorbierbaren Platzhalters (InSpace Balloon®, ISB) in den Subakromialraum dar. Dieser führt zur Rezentrierung des Humeruskopfes und zur Reduktion subakromialer Scherkräfte. Ziel dieser Studie ist die Evaluation der klinischen Ergebnisse arthroskopisch therapierter Patienten mit MRCT mit oder ohne zusätzlichen ISB.

          Methoden

          Retrospektiv wurden die klinischen Ergebnisse konventionell-arthroskopisch behandelter Patienten ( n = 11, Gruppe A, Partialrekonstruktion, Bizepssehnentenotomie- oder tenodese und Débridement) und von Patienten mit zusätzlichem ISB ( n = 12, Gruppe B) untersucht.

          Prä- und postoperativ wurde die Schulterfunktion mittels Constant- und American-Shoulder-and-Elbow-Surgeons(ASES)-Score untersucht. Nach durchschnittlich 22 Monaten füllten die Patienten einen Fragebogen zur subjektiven Patientenzufriedenheit aus.

          Ergebnisse

          Zum Nachuntersuchungszeitpunkt wiesen beide Gruppen eine verbesserte Schulterfunktion auf (Constant-Score in Gruppe A: von 60,7 auf 77,6; p < 0,001; Constant-Score in Gruppe B: von 36,8 auf 69,5; p < 0,001 und ASES-Score in Gruppe A: von 59,1 auf 88,6; p < 0,001; ASES-Score in Gruppe B: von 31,5 auf 85,7; p < 0,001). Die absolute Verbesserung der Scores war für Patienten mit einem ISB höher. Beide Gruppen waren subjektiv mit dem Operationsergebnis zufrieden.

          Schlussfolgerung

          Der ISB stellt eine praktikable Therapieoption bei MRCT dar, die mit subjektiver Schmerzlinderung und verbesserter Schulterfunktion einhergeht. Weitere Studien mit größeren Patientenkollektiven und längerem Follow-up sind nötig, um die Sicherheit und Kosteneffizienz dieser Behandlung zu bestätigen.

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          Most cited references14

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          Arthroscopic repair of massive rotator cuff tears with stage 3 and 4 fatty degeneration.

          The purpose of this study was to assess the functional results of arthroscopic repair of massive rotator cuff tears in patients who had stage 3 and 4 fatty degeneration of the rotator cuff musculature, according to the Goutallier scale. From January 1997 to December 2001, 22 patients with massive rotator cuff tears and Goutallier stage 3 or 4 fatty degeneration of the infraspinatus, with a mean age of 66.5 +/- 9.26 years, underwent arthroscopic rotator cuff repair and were available for follow-up. The average tear size was 4.8 +/- 0.85 cm in medial-to-lateral width and 6.2 +/- 1.53 cm in anterior-to-posterior length, with an approximate tear size area of 30.0 +/- 10.0 sq cm, and involved 2 tendons (supraspinatus and infraspinatus) or 3 tendons (supraspinatus, infraspinatus, and subscapularis) in each case. The mean time from surgery to follow-up was 39.3 months (range, 24-60 months). In addition to comparison of preoperative and postoperative range of motion, strength and University of California, Los Angeles (UCLA) score, outcomes were also assessed with the Constant score. The increase of mean active forward elevation was 53.7 degrees (preoperative: 103.2 degrees and postoperatively: 156.9 degrees ). The gain of mean active external rotation was 19.1 degrees (preoperative: 35.7 degrees and postoperative: 54.8 degrees). The gain of mean external rotation power was 1.9 (preoperative: 2.3 and postoperative: 4.2). The improvement in the UCLA score was 17.2 points (preoperative: 12.3 and postoperative: 29.5). The mean postoperative Constant score was 74.8/100, and the weighted postoperative Constant score was 88.5/100. In 5 patients with fatty degeneration greater than 75% (advanced stage 4), results were less dramatically improved than in 17 patients with fatty degeneration of 50% to 75%, all of whom exhibited clinical improvement. However, clinical improvement was achieved even in 2 of 5 patients with advanced stage 4 involvement. Arthroscopic rotator cuff repair in patients with grade 3 or 4 fatty degeneration (> or =50%) can provide significant functional improvement. Those with 50% to 75% fatty degeneration showed a much greater degree of improvement (with all 17 cases exhibiting beneficial postoperative increases in their UCLA scores ranging from 12 to 26 points) than those with >75% fatty degeneration (with only 2 of 5 cases showing an increase of 10 or more points in their UCLA scores). However, clinical improvement was observed in 86.4% of cases that would have been classified as likely to fail by the Goutallier criteria. Level IV, therapeutic case series.
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            Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears.

            The purposes of this prospective non-randomized study were to confirm the feasibility of the biodegradable sub-acromial spacer (InSpace™) implantation in patients with massive irreparable rotator cuff tear and to determine the safety profile and functional results 3 years post-implantation. Twenty patients were implanted with the InSpace™ device and assessed up to 3 years of post-implantation. Improvement in shoulder function was assessed using Constant score, while ease of use of the system was recorded by surgeons as were device-related adverse events. Twenty patients were available for assessment. Implantation was performed arthroscopically in all patients, and a range of deployment time was 2-20 min. The mean total Constant score increased from 33.4 to 65.4 points at 3 years. There was an improvement of 6.4 points in subjective pain score which commenced at 1 week post-operatively and was sustained until 3 years of follow-up. Also activities of daily living and motions commenced improvement by 9.4 and 7.7 points, respectively. Improvement in power was only evident at 18 months of follow-up but was sustained at 3 years. Arthroscopic deployment of a co-polymer biodegradable spacer (balloon) into the sub-acromial space for an irreparable rotator cuff tear was found to be low-risk and simple procedure associated with improvement in shoulder function and low rate of complications. IV; therapeutic case series.
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              Is Open Access

              New solution for massive, irreparable rotator cuff tears: the subacromial "biodegradable spacer".

              Massive, irreparable rotator cuff tears are a source of pain and disability. Although most rotator cuff tears can be completely repaired, a significant number are considered massive and irreparable. Numerous operative techniques have been described for the treatment of these kinds of tears including arthroscopic debridement, biceps tenotomy, tendon transfer, grafting, and reverse arthroplasty. We describe a surgical technique using a biodegradable subacromial balloon spacer (InSpace; OrthoSpace, Kfar Saba, Israel) implanted between the humeral head and acromion that permits smooth, frictionless gliding, restoring the shoulder biomechanics. The technique is easy to perform and is less invasive than the conventional surgical techniques available, and it may potentially serve as a bridging option in patients with massive, irreparable tears who are normally candidates for reverse arthroplasty.
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                Author and article information

                Contributors
                +49-174-9209191 , holmal@web.de
                brand.florian@gmx.de
                jens.agneskirchner@g-o-hannover.de
                Journal
                Obere Extrem
                Obere Extrem
                Obere Extremitat
                Springer Medizin (Munich )
                1862-6599
                1862-6602
                1 December 2016
                1 December 2016
                2017
                : 12
                : 1
                : 38-45
                Affiliations
                [1 ]Raphaelsklinik Münster, Schuerbusch 55, 48143 Münster, Germany
                [2 ]GRID grid.10423.34, ISNI 0000000095299877, Medizinische Hochschule Hannover, ; Hannover, Germany
                [3 ]Klinik für Gelenkchirurgie und Orthopädie (GOH), Hannover, Germany
                Author information
                http://orcid.org/0000-0002-7293-2224
                Article
                386
                10.1007/s11678-016-0386-9
                5579412
                28868086
                3ea1783d-9061-4e11-a819-5aba92aae7a7
                © Springer Medizin Verlag Berlin 2016
                History
                : 5 September 2016
                : 4 November 2016
                Categories
                Original Contribution
                Custom metadata
                © Springer Medizin Verlag GmbH 2017

                acromion,shoulder,cuff, rotator,debridement,arthroscopic surgery,akromion,schulter,rotatorenmanschette,débridement,arthroskopischer eingriff

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