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OpenTrials
Completed

NCT Number: NCT05010278

Evaluation of Factors Associated With Return to Sports Activity Six Months After Anterior Shoulder Stabilisation With Latarjet.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du Sport

Paris, 75005, France

About this study

Primary objective:

to assess the impact of patients' psychological state on failure to return to sport.

Secondary objectives:

  • To compare the functional assessment of the shoulder of patients for whom return to sport is successful or unsuccessful (Walch score, isokinetic tests and CKCUES Test score)
  • To describe the factors associated with failure to return to sport

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Latarjet

Procedure

Patients followed up 6 months after a Latarjet procedure

Primary outcomes

  1. SISRI score

    Time frame: 6 months

    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.

Secondary outcomes

  1. Walch-Duplay Score for Instability of the Shoulder

    Time frame: 6 months

    Walch-Duplay Score for Instability of the Shoulder

  2. Isokinetic test: peak force

    Time frame: 6 months

    peak force (in newton-metre)

  3. Isokinetic test: relative peak force

    Time frame: 6 months

    relative peak force: peak force/body weight (in newton/kilogram)

  4. Isokinetic test: eccentric peak force

    Time frame: 6 months

    eccentric peak force achieved in external stroke

  5. Closed kinetic chain upper extremity stability (CKCUES) test

    Time frame: 6 months

    The Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) is a tool developed and used in the clinic to evaluate progress during upper extremity rehabilitation. A need exists for reference values of CKCUEST for use in a clinical setting.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ERASME

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2021
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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