Evaluation of the Long-term Outcome of Dorsal Ligamentoplasty Reinforced With an Internal Brace in the Treatment of Scapholunate Instability (ELIS)

September 5, 2025 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche
Prospective longitudinal multicenter observational cohort study conducted on a population of patients who underwent ligamentoplasty for scapholunate instability and agreed to be followed for a period of five years from the day of hospital discharge.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France, 13008
        • Recruiting
        • Clinique Monticelli - Vélodrome
        • Contact:
        • Sub-Investigator:
          • Caroline CURVALE, MD
        • Sub-Investigator:
          • Philippe SAMSON, MD
        • Sub-Investigator:
          • André́ GAY, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent ligamentoplasty for scapholunate instability

Description

Inclusion Criteria:

  • Patient over 18 years old who has been informed about the study and has not objected to the use of their personal data
  • Patient who has undergone dorsal ligamentoplasty reinforced with an internal brace for scapholunate instability

Exclusion Criteria:

  • Mental deficiency or any other reason that may interfere with understanding or strict application of the protocol
  • Patient under legal protection, guardianship, or conservatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ligamentoplasty failure
Time Frame: Year 5
Failure of the ligamentoplasty is defined by the need for secondary surgery.
Year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-A00650-45

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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