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

NCT ID: NCT06493318

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-24

Study Completion Date

2031-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Wrist Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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®), 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Monticelli - Vélodrome

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Aurélie INIESTA, MD

Role: CONTACT

04 91 16 22 22 ext. 33

Facility Contacts

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Aurélie INIESTA, MD

Role: primary

4 91 16 22 22 ext. 33

Other Identifiers

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2023-A00650-45

Identifier Type: -

Identifier Source: org_study_id

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