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

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: Wrist Disease
• Intervention / Treatment: Procedure: Dorsal ligamentoplasty reinforced with an internal brace

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Aurélie INIESTA, MD; Phone Number: 33 04 91 16 22 22; Email: aurelie.iniesta@gmail.com

Study Locations

• France
  • Marseille, France, 13008
    • Recruiting
    • Clinique Monticelli - Vélodrome
    • Contact: Aurélie INIESTA, MD; Phone Number: 33 4 91 16 22 22; Email: aurelie.iniesta@gmail.com
    • Sub-Investigator: Caroline CURVALE, MD
    • Sub-Investigator: Philippe SAMSON, MD
    • Sub-Investigator: André́ GAY, MD

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

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