Recruiting NCT06493318
Evaluation of the Long-term Outcome of Dorsal Ligamentoplasty Reinforced With an Internal Brace in the Treatment of Scapholunate Instability
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dorsal ligamentoplasty reinforced with an internal brace.
- Who it may be relevant to
- Registry conditions: Wrist Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Dorsal ligamentoplasty reinforced with an internal brace
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
Primary outcome measures
- Ligamentoplasty failure [Time frame: Year 5]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Clinique Monticelli - Vélodrome — Marseille
Identifiers
NCT: NCT06493318 · 2023-A00650-45