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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06493318
Acronym
ELIS
Enrollment
35
Registered
2024-07-09
Start date
2024-04-24
Completion date
2031-05-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wrist Disease

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.

Interventions

PROCEDUREDorsal 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.

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ligamentoplasty failureYear 5Failure of the ligamentoplasty is defined by the need for secondary surgery.

Countries

France

Contacts

Primary ContactAurélie INIESTA, MD
aurelie.iniesta@gmail.com04 91 16 22 22

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026