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NCT06145815 Clinical Trial

Machine Learning Predictive Model for Rotator Cuff Repair Failure

Rotator Cuff Tears Clinical Trial

Official title:
Predictive Model for Minimal Important Change After Rotator Cuff Repair Using Machine Learning Methods: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06145815
Other study ID # CCER #2020-02670
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date November 1, 2023

Study information
Verified date November 2023
Source La Tour Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There is little overall evidence behind clinical practice guidelines for diagnosis and treatment of rotator cuff repair. The purpose of this study was to compare the performance of different machine learning models that use pre-operative data from an international and multicentric database to predict if a patient that underwent rotator cuff repair could achieve the minimal important change (MIC) for single assessment numeric evaluation (SANE) at one year follow-up.

Recruitment information / eligibility
Status Completed
Enrollment 4789
Est. completion date November 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Primarily treated for rotator cuff tears by partial or complete surgical repair with a planned arthroscopic procedure - Reparable tears - No language barrier hindering questionnaire completion or legal incompetence were not included Exclusion Criteria: - missing pre- or post-operative single-assessment numeric evaluation (SANE)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Arthroscopic rotator cuff repair
Patients underwent an arthroscopic repair for rotator cuff lesions

Locations
Country Name City State
Switzerland La Tour hospital Meyrin Geneva

Sponsors (1)
Lead Sponsor Collaborator
La Tour Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary SANE score Single Assessment Numeric Evaluation (SANE). From 0 (worst) to 100 (best). At 12 post-operative months
See also
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Not yet recruiting NCT04538001 - Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear N/A
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Completed NCT04710966 - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears N/A
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Recruiting NCT05925881 - Lower Trapezius Transfer vs Bridging Reconstruction N/A
Recruiting NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. N/A
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