Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06493318

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
35 (estimated)
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREDorsal ligamentoplasty reinforced with an internal braceAfter 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.

Timeline

Start date
2024-04-24
Primary completion
2031-05-01
Completion
2031-05-01
First posted
2024-07-09
Last updated
2025-09-08

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06493318. Inclusion in this directory is not an endorsement.