NCT05010278

Brief Summary

On a population of sports patients who had undergone a Latarjet operation for post-traumatic anterior shoulder instability, reviewed in consultation 6 months after the operation as part of an ordinary follow-up and divided into two groups according to their current sports practice. Group 1: "SUCCESS": return to the same level in the same sport. Group 2: "FAILURE": return to the same sport with a reduced level or change of sport or significant reduction or cessation of sporting activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

August 16, 2021

Last Update Submit

June 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • SISRI score

    The Shoulder Instability-Return to Sport after Injury (SIRSI) score will be compared between groups by a Student's t test or by a non-parametric Mann-Whitney test.

    6 months

Secondary Outcomes (5)

  • Walch-Duplay Score for Instability of the Shoulder

    6 months

  • Isokinetic test: peak force

    6 months

  • Isokinetic test: relative peak force

    6 months

  • Isokinetic test: eccentric peak force

    6 months

  • Closed kinetic chain upper extremity stability (CKCUES) test

    6 months

Study Arms (1)

Latarjet

Patients followed up 6 months after a Latarjet procedure

Procedure: Latarjet

Interventions

LatarjetPROCEDURE

Patients followed up 6 months after a Latarjet procedure

Latarjet

Eligibility Criteria

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

Patients followed up 6 months after a Latarjet procedure.

You may qualify if:

  • Patient aged 18 years or older, having been informed of the research
  • Sports patients who have expressed their desire to resume their sporting activity
  • Patient who has undergone a first intention Latarjet operation
  • Patient regularly monitored since the operation and for whom all the data collected during the six-month follow-up visit are available

You may not qualify if:

  • Patient operated for revision surgery
  • Patient with an associated rotator cuff or biceps injury
  • Patient under court protection, guardianship or curatorship
  • Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique du Sport

Paris, 75005, France

Location

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder Injuries

Study Officials

  • Alexandre HARDY, MD

    Clinique du sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 18, 2021

Study Start

September 30, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations