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NCT Number: NCT06493318

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

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.

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Key information

Conditions

Wrist Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Monticelli - Vélodrome

Marseille, 13008, France

Location status: Recruiting

Location contact

André́ GAY, MD

SUB_INVESTIGATOR

Aurélie INIESTA, MD

CONTACT

[email protected]

4 91 16 22 22 ext. 33

Caroline CURVALE, MD

SUB_INVESTIGATOR

Philippe SAMSON, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Ligamentoplasty failure

    Time frame: Year 5

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

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie INIESTA, MD

CONTACT

[email protected]

04 91 16 22 22 ext. 33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ELIS

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Jul 9, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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