NCT06145815

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,789

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

Same day

First QC Date

November 17, 2023

Last Update Submit

November 24, 2023

Conditions

Rotator Cuff Tears

Keywords

Artificial intelligenceMachine LearningMinimal Important Change

Outcome Measures

Primary Outcomes (1)

  • SANE score

    Single Assessment Numeric Evaluation (SANE). From 0 (worst) to 100 (best).

    At 12 post-operative months

Study Arms (2)

MIC RCR patients

Patients who improved their SANE score beyond the minimal important change one year after arthroscopic rotator cuff repair

Procedure: Arthroscopic rotator cuff repair

No-MIC RCR patients

Patients who did not improve their SANE score beyond the minimal important change one year after arthroscopic rotator cuff repair

Procedure: Arthroscopic rotator cuff repair

Interventions

Arthroscopic rotator cuff repairPROCEDURE

Patients underwent an arthroscopic repair for rotator cuff lesions

MIC RCR patientsNo-MIC RCR patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients who were primarily treated for rotator cuff tears by partial or complete surgical repair with a planned arthroscopic procedure were included in study.

You may qualify if:

  • 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

You may not qualify if:

  • missing pre- or post-operative single-assessment numeric evaluation (SANE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Tour hospital

Meyrin, Canton of Geneva, 1217, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Alexandre Lädermann, MD

    La Tour hospital, Meyrin (1217) Geneva, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

September 1, 2022

Primary Completion

September 1, 2022

Study Completion

November 1, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

CH(1)