Surgical Safety and Effectiveness in Orthopedics: Swiss-wide Multicenter Evaluation and Prediction of Core Outcomes in Arthroscopic Rotator Cuff Reconstruction
NCT ID: NCT04321005
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
973 participants
OBSERVATIONAL
2020-06-01
2024-11-13
Brief Summary
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Detailed Description
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Ultrasound and MRI (on a subset of patients) examination will be performed at 12 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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arthroscopic rotator cuff reconstruction
arthroscopic rotator cuff reconstruction and assessment with evaluation and prediction of core outcomes
Eligibility Criteria
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Inclusion Criteria
* diagnosed with a partial or full-thickness rotator cuff tear using magnetic resonance imaging (MRI)
* planned primarily surgical partial or complete repair by arthroscopic procedure
* able to understand the content of the patient information/ consent form and give consent to take part in the project
Exclusion Criteria
* revision surgery (prior repair of the rotator cuff in the same shoulder)
* planned open or mini-open reconstructions
* patients with a language barrier hindering questionnaire completion (either in German, French, Italian or English)
* patients unlikely to attend clinical follow-up
* pregnancy
* legal incompetence
18 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
Swiss Orthopaedics
UNKNOWN
Schweizerische Versicherungsanstalt (SUVA)
UNKNOWN
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Andreas Müller, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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Department for Shoulder and Elbow surgery Center for Musculoskeletal Surgery Campus Virchow
Berlin, , Germany
Kantonsspital Baden AG,
Baden, Aarau, Switzerland
Kantonsspital Baselland
Binningen, Basel-Landschaft, Switzerland
Hirslanden Klinik Birshof
Münchenstein, Basel-Landschaft, Switzerland
Klinik tür Orthopädische Chirurgie und Traumatologie des Bewegungsapparates Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Zentrum für Orthopädie & Neurochirurgie In-Motion
Wallisellen, Canton of Zurich, Switzerland
Klinik Gut
St. Moritz, Kanton Graubünden, Switzerland
Hopital du Valois (RSV)
Martigny-Ville, Valais, Switzerland
University Hospital Basel
Basel, , Switzerland
ARTHRO Medics AG
Basel, , Switzerland
Sonnenhof
Bern, , Switzerland
Inselspital
Bern, , Switzerland
Hirslanden Clinique de Colline
Geneva, , Switzerland
University Hospital Geneva
Geneva, , Switzerland
Regional Hospital Lugano
Lugano, , Switzerland
Bürgerspital Solothurn, Klinik für Orthopädie und Traumatologie
Solothurn, , Switzerland
Kantonsspital Winterthur, Klinik für Orthopädie und Traumatologie
Winterthur, , Switzerland
Schulthess Klinik
Zurich, , Switzerland
Universitätsklinik Balgrist
Zurich, , Switzerland
Endoclinic
Zurich, , Switzerland
Countries
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References
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Audige L, Bucher HCC, Aghlmandi S, Stojanov T, Schwappach D, Hunziker S, Candrian C, Cunningham G, Durchholz H, Eid K, Flury M, Jost B, Ladermann A, Moor BK, Moroder P, Rosso C, Schar M, Scheibel M, Spormann C, Suter T, Wieser K, Zumstein M; ARCR_Pred Study Group; Muller AM. Swiss-wide multicentre evaluation and prediction of core outcomes in arthroscopic rotator cuff repair: protocol for the ARCR_Pred cohort study. BMJ Open. 2021 Apr 22;11(4):e045702. doi: 10.1136/bmjopen-2020-045702.
Other Identifiers
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2019-02076; ch20Mueller
Identifier Type: -
Identifier Source: org_study_id