Scapholunate DissociationNCT06236204
Arthroscopic Scapholunate Ligament Reconstruction
A study testing Arthroscopic Scapholunate Ligament Reconstruction in people with Scapholunate Dissociation, run by Regionaal Ziekenhuis Heilig Hart Tienen at 1 site in Belgium.
Trial summary
Arthroscopical reconstruction of the volar and dorsal part of the scapholunate ligament as treatment for complete scapholunate ligament injury, but reducible carpal malalignment. This prospective study aims to evaluate the clinical and functional outcome of this technique on the short and middle term Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Scapholunate Dissociation
- What is being tested?
- Arthroscopic Scapholunate Ligament Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scapholunate dysfunction, complete irrepairable lesion of the SL ligament and the secondary stabilizers (RSC-LRL-SRL) EWAS stage 4-5, no arthritis, with reducible malalignment
- 18 - 65 years
Who cannot join
- - associated lesions, fractures
- neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Scapholunate Ligament Reconstruction, Volar and Dorsal Reconstruction, as Treatment for Dysfunction of the Scapholunate Joint With Insufficiency of the Scapholunate Ligament and Secondary Stabilizers
Arthroscopical reconstruction of the volar and dorsal part of the scapholunate ligament as treatment for complete scapholunate ligament injury, but reducible carpal malalignment.
This prospective study aims to evaluate the clinical and functional outcome of this technique on the short and middle term
Read the detailed description
Classical arthroscopic techniques for scapholunate instability consist of debridement, thermal shrinkage, and percutaneous pinning. Good results are obtained in acute lesions or in chronic partial tears, but they are less predictable when the lesion is complete, because of the poor healing capacity of the scapholunate ligament and because it is not possible to perform an anatomic ligamentous reconstruction with these techniques. Open techniques are thus required for reconstruction, but they damage the soft tissues. Corella et al. published a description and cadaver study of an arthroscopic ligamentoplasty, trying to combine the advantages of arthroscopic techniques (minimally invasive surgery) and open techniques (reconstruction of the ligament). With this approach, it is possible to reconstruct the dorsal scapholunate ligament and the secondary stabilizers while causing minimal damage to the soft tissues and avoiding injury to the posterior interosseous nerve and detachment of the dorsal intercarpal ligament. Arthroscopic scapholunate volar and dorsal ligament reconstruction achieves an anatomic reconstruction to provide a strong construct for early mobilization.
- Conditions
- Scapholunate Dissociation
- Being tested
- Arthroscopic Scapholunate Ligament Reconstruction
- Keywords
- scapholunate instability, reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Scapholunate Ligament ReconstructionProcedure or surgery
reconstruction of the SL ligament with palmaris tendon graft tunneled through the scaphoid and lunate as described by Corella et al.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Scapholunate Ligament Reconstruction | Experimental | Experimental: patients with dynamic scapholunate instability wrist arthroscopy: bone-tendon reconstruction of the volar and dorsal part of the scapholunate complex Receives: Procedure: Arthroscopic Scapholunate Ligament Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
passive and active range of motion (degrees) operated and contralateral side
flexion, extension, ulnar and radial deviation
Measured: preop
passive and active range of motion (degrees) operated and contralateral side
flexion, extension, ulnar and radial deviation
Measured: postoperative 3 months
passive and active range of motion (degrees) operated and contralateral side
flexion, extension, ulnar and radial deviation
Measured: postoperative 6 months
passive and active range of motion (degrees) operated and contralateral side
flexion, extension, ulnar and radial deviation
Measured: postoperative 12 months
grip strength (kg) operated and contralateral side
dynamometer (kg)
Measured: preop
grip strength (kg) operated and contralateral side
dynamometer (kg)
Measured: postoperative 3 months
grip strength (kg) operated and contralateral side
dynamometer (kg)
Measured: postoperative 6 months
grip strength (kg) operated and contralateral side
dynamometer (kg)
Measured: postoperative 12 months
pain (visual analogue scale)
Visual analogue Scale (0 no pain -10 cm worst pain)
Measured: preop
pain (visual analogue scale)
Visual analogue Scale Scale (0 no pain -10 cm worst pain)
Measured: postoperative 3 months
pain (visual analogue scale)
Visual analogue Scale Scale (0 no pain -10 cm worst pain)
Measured: postoperative 6 months
pain (visual analogue scale)
Visual analogue Scale (0 no pain -10 cm worst pain)
Measured: postoperative 12 months
Disabilities of the Arm, Shoulder and Hand score
function score (0 is best -100 is worst)
Measured: preop
Disabilities of the Arm, Shoulder and Hand score
function score (0 is best -100 is worst)
Measured: postoperative 3 months
Disabilities of the Arm, Shoulder and Hand score
function score (0 is best -100 is worst)
Measured: postoperative 6 months
Disabilities of the Arm, Shoulder and Hand score
function score (0 is best -100 is worst)
Measured: postoperative 12 months
Secondary outcomes (5)
patient satisfaction after treatment
visual analogue scale (0 is worst -10 cm is best)
Measured: postoperative 12 months
complications
descriptive
Measured: postoperative 12 months
arthroscopical assessment of the scapholunate stability
according to European Wrist Arthroscopy Society classification (EWAS1 best -5 worst)
Measured: intraoperative
scapholunate distance, carpal angles
radiological follow-up (distance in mm or angles in degrees)
Measured: preop
scapholunate distance, carpal angles
radiological follow-up (distance in mm or angles in degrees)
Measured: postoperative 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapholunate DissociationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective single center - single surgeon
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionaal Ziekenhuis Heilig Hart Tienen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goorens Chul Ki, Regionaal Ziekenhuis Heilig Hart Tienen
- Investigators
- Kjell Van Royen, MD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236204
- Sponsor's protocol ID
- RZ Tienen EC 109
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2023
- Last updated
- 1 Feb 2024
- 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Scapholunate Ligament Reconstruction, Volar and Dorsal Reconstruction, as Treatment for Dysfunction of the Scapholunate Joint With Insufficiency of the Scapholunate Ligament and Secondary Stabilizers
- ClinicalTrials.gov ID
- NCT06236204
- Acronym / sponsor ID
- RZ Tienen EC 109
- Conditions
- Scapholunate Dissociation
- Keywords
- scapholunate instability, reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Regionaal Ziekenhuis Heilig Hart TienenUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Feb 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.
Arthroscopical reconstruction of the volar and dorsal part of the scapholunate ligament as treatment for complete scapholunate ligament injury, but reducible carpal malalignment.
This prospective study aims to evaluate the clinical and functional outcome of this technique on the short and middle term
Detailed description
Classical arthroscopic techniques for scapholunate instability consist of debridement, thermal shrinkage, and percutaneous pinning. Good results are obtained in acute lesions or in chronic partial tears, but they are less predictable when the lesion is complete, because of the poor healing capacity of the scapholunate ligament and because it is not possible to perform an anatomic ligamentous reconstruction with these techniques. Open techniques are thus required for reconstruction, but they damage the soft tissues. Corella et al. published a description and cadaver study of an arthroscopic ligamentoplasty, trying to combine the advantages of arthroscopic techniques (minimally invasive surgery) and open techniques (reconstruction of the ligament). With this approach, it is possible to reconstruct the dorsal scapholunate ligament and the secondary stabilizers while causing minimal damage to the soft tissues and avoiding injury to the posterior interosseous nerve and detachment of the dorsal intercarpal ligament. Arthroscopic scapholunate volar and dorsal ligament reconstruction achieves an anatomic reconstruction to provide a strong construct for early mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective single center - single surgeon
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Scapholunate Ligament Reconstruction | Experimental | Procedure: Arthroscopic Scapholunate Ligament ReconstructionExperimental: patients with dynamic scapholunate instability wrist arthroscopy: bone-tendon reconstruction of the volar and dorsal part of the scapholunate complex |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scapholunate dysfunction, complete irrepairable lesion of the SL ligament and the secondary stabilizers (RSC-LRL-SRL) EWAS stage 4-5, no arthritis, with reducible malalignment
- 18 - 65 years
Key exclusion criteria (2 listed)
- - associated lesions, fractures
- neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist
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 |
|---|---|---|
| Arthroscopic Scapholunate Ligament Reconstructionreconstruction of the SL ligament with palmaris tendon graft tunneled through the scaphoid and lunate as described by Corella et al. | Procedure or surgery | Arthroscopic Scapholunate Ligament Reconstruction |
Primary outcome
passive and active range of motion (degrees) operated and contralateral side
Time frame: preop
flexion, extension, ulnar and radial deviation
passive and active range of motion (degrees) operated and contralateral side
Time frame: postoperative 3 months
flexion, extension, ulnar and radial deviation
passive and active range of motion (degrees) operated and contralateral side
Time frame: postoperative 6 months
flexion, extension, ulnar and radial deviation
passive and active range of motion (degrees) operated and contralateral side
Time frame: postoperative 12 months
flexion, extension, ulnar and radial deviation
grip strength (kg) operated and contralateral side
Time frame: preop
dynamometer (kg)
grip strength (kg) operated and contralateral side
Time frame: postoperative 3 months
dynamometer (kg)
grip strength (kg) operated and contralateral side
Time frame: postoperative 6 months
dynamometer (kg)
grip strength (kg) operated and contralateral side
Time frame: postoperative 12 months
dynamometer (kg)
pain (visual analogue scale)
Time frame: preop
Visual analogue Scale (0 no pain -10 cm worst pain)
pain (visual analogue scale)
Time frame: postoperative 3 months
Visual analogue Scale Scale (0 no pain -10 cm worst pain)
pain (visual analogue scale)
Time frame: postoperative 6 months
Visual analogue Scale Scale (0 no pain -10 cm worst pain)
pain (visual analogue scale)
Time frame: postoperative 12 months
Visual analogue Scale (0 no pain -10 cm worst pain)
Disabilities of the Arm, Shoulder and Hand score
Time frame: preop
function score (0 is best -100 is worst)
Disabilities of the Arm, Shoulder and Hand score
Time frame: postoperative 3 months
function score (0 is best -100 is worst)
Disabilities of the Arm, Shoulder and Hand score
Time frame: postoperative 6 months
function score (0 is best -100 is worst)
Disabilities of the Arm, Shoulder and Hand score
Time frame: postoperative 12 months
function score (0 is best -100 is worst)
5 secondary outcomes
patient satisfaction after treatment
Time frame: postoperative 12 months
complications
Time frame: postoperative 12 months
arthroscopical assessment of the scapholunate stability
Time frame: intraoperative
scapholunate distance, carpal angles
Time frame: preop
scapholunate distance, carpal angles
Time frame: postoperative 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
Related trials for Scapholunate Dissociation
RecruitingObservational study
Scapholunate Ligament Reconstruction Using Modified Flexor Carpi Radialis Tenodesis
Scapholunate Dissociation, Scapholunate Ligament Rupture
Active, not recruitingObservational study
Comparison of Strength, Weight Bearing, Proprioception, Reaction Time and Function in Scapholunate Instability
Scapholunate Interosseous Ligament Injury, Scaphoid-Lunate Instability
Not yet recruiting
Diagnosing Dynamic Scapholunate Instability with Computer Tomography
Scapholunate Dissociation
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. This study is not recruiting at the moment.
Kjell Van Royen, MD study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Scapholunate Ligament Reconstruction in people with Scapholunate Dissociation, run by Regionaal Ziekenhuis Heilig Hart Tienen at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chul ki goorens, MD (0032478907124, cgoorens@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
passive and active range of motion (degrees) operated and contralateral side (time frame: preop). The study lists 16 primary outcomes in all. 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 1 Feb 2024; AzTrials last refreshed its copy on 31 Oct 2026.