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

NCT06493318 | Recruiting

• 1 other identifier: 2023-A00650-45
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wrist Disease

Outcome Measures

Primary Outcomes (1)

• Ligamentoplasty failure

  Failure of the ligamentoplasty is defined by the need for secondary surgery.

  Year 5

Interventions

Dorsal ligamentoplasty reinforced with an internal brace PROCEDURE

After a longitudinal dorsal incision of the wrist, an ECRB (extensor carpi radialis brevis) or palmaris longus hemi-tendon is harvested. The scapholunate positioning is adjusted using joystick pins. A 2.5 mm blind tunnel is made in the lunate and two 2.5 mm blind tunnels are made in the proximal and distal poles of the scaphoid. The tendon graft is threaded using a fiberloop and reinforced with suture tape. The graft is fixed in the proximal pole of the scaphoid with a swive-lock anchor (Arthrex®), then in the lunate, and finally fixed in the distal pole of the scaphoid by the same method. An anti-rotation scapho-capitate pin is then placed. This is maintained for 6 weeks during post-operative immobilization with a wrist orthosis. Rehabilitation begins after the pin is removed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent ligamentoplasty for scapholunate instability

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Clinique Monticelli - Vélodrome

Marseille, 13008, France

RECRUITING

Central Study Contacts

Aurélie INIESTA, MD

CONTACT

04 91 16 22 22; aurelie.iniesta@gmail.com

Study Design

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

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 9, 2024
• Study Start: April 24, 2024
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

FR (1)