Status:
COMPLETED
Surgical Safety and Effectiveness in Orthopedics: Swiss-wide Multicenter Evaluation and Prediction of Core Outcomes in Arthroscopic Rotator Cuff Reconstruction
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Swiss National Science Foundation
Swiss Orthopaedics
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18+ years
Brief Summary
Surgical safety and effectiveness in orthopedics: Swiss-wide multicenter evaluation and prediction of core outcomes in arthroscopic rotator cuff reconstruction.
Detailed Description
In this project prospective data are collected from a representative group of specialized clinics performing arthroscopic rotator cuff repair (ARCR) to serve as reference baseline and outcome values, ...
Eligibility Criteria
Inclusion
- adult patients
- 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
- surgical procedure for irreparable tears, i.e. muscle transfer, acromio-humeral spacer or superior capsular reconstruction
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 13 2024
Estimated Enrollment :
973 Patients enrolled
Trial Details
Trial ID
NCT04321005
Start Date
June 1 2020
End Date
November 13 2024
Last Update
December 4 2024
Active Locations (20)
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1
Department for Shoulder and Elbow surgery Center for Musculoskeletal Surgery Campus Virchow
Berlin, Germany, 13353
2
Kantonsspital Baden AG,
Baden, Aarau, Switzerland, 5404
3
Kantonsspital Baselland
Binningen, Basel-Landschaft, Switzerland, 4104
4
Hirslanden Klinik Birshof
Münchenstein, Basel-Landschaft, Switzerland, 4142