Wrist DiseaseELISNCT06493318
Evaluation of the Long-term Outcome of Dorsal Ligamentoplasty Reinforced With an Internal Brace in the Treatment of Scapholunate Instability
An observational study of Wrist Disease, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Disease
- What is being tested?
- Dorsal ligamentoplasty reinforced with an internal brace
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2024to 1 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent ligamentoplasty for scapholunate instability
Who may be able to join
- 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
Who cannot join
- Mental deficiency or any other reason that may interfere with understanding or strict application of the protocol
- Patient under legal protection, guardianship, or conservatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Monticelli - Vélodrome
Marseille, 13008
Aurélie INIESTA, MD, 4 91 16 22 22 ext. 33, aurelie.iniesta@gmail.com
Caroline CURVALE, MD
About this study
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
- Wrist Disease
- Being tested
- Dorsal ligamentoplasty reinforced with an internal brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal ligamentoplasty reinforced with an internal braceProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ligamentoplasty failure
Failure of the ligamentoplasty is defined by the need for secondary surgery.
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start24 Apr 2024
- Primary completion1 May 2031 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist DiseaseStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493318
- Sponsor's protocol ID
- 2023-A00650-45
- Acronym
- ELIS
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long-term Outcome of Dorsal Ligamentoplasty Reinforced With an Internal Brace in the Treatment of Scapholunate Instability
- ClinicalTrials.gov ID
- NCT06493318
- Acronym / sponsor ID
- ELIS / 2023-A00650-45
- Conditions
- Wrist Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent ligamentoplasty for scapholunate instability
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Mental deficiency or any other reason that may interfere with understanding or strict application of the protocol
- Patient under legal protection, guardianship, or conservatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorsal 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. | Procedure or surgery | – |
Primary outcome
Ligamentoplasty failure
Time frame: Year 5
Failure of the ligamentoplasty is defined by the need for secondary surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrist Disease, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélie INIESTA, MD (04 91 16 22 22 ext. 33, aurelie.iniesta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ligamentoplasty failure (time frame: Year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.