Scapholunate Interosseous Ligament Injurycase seriesNCT06925230
Arthroscopic Assisted Volar, Dorsal or Combined Capsulodesis in Scapholunate Ligament Injury.
A study testing arthroscopic assisted volar scapholunate capsulodesis, arthroscopic assisted dorsal scapholunate capsulodesis and arthroscopic assisted combined volar and dorsal scapholunate capsulodesis in people with Scapholunate Interosseous Ligament Injury and SLLI, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this case series study is to test the efficacy of arthroscopic assisted volar, dorsal or combined scapholunate capsulodesis in the management of scapholunate ligament injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scapholunate Interosseous Ligament Injury, SLLI
- What is being tested?
- arthroscopic assisted volar scapholunate capsulodesis, arthroscopic assisted dorsal scapholunate capsulodesis and arthroscopic assisted combined volar and dorsal scapholunate capsulodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to 10 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex: both sexes.
- Age: above 18 years
- Lesion: subacute or chronic scapholunate ligament injury
- partial and complete SLIL tears
Who cannot join
- Acute scapholunate ligament injury
- irreducible carpal malalignment
- posttraumatic arthritis
- associated fractures that could affect the functional outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Assisted Volar, Dorsal or Combined Capsulodesis in Scapholunate Ligament Injury
The aim of this case series study is to test the efficacy of arthroscopic assisted volar, dorsal or combined scapholunate capsulodesis in the management of scapholunate ligament injuries.
Read the detailed description
The aim of this case series study is to test the efficacy of arthroscopic assisted volar, dorsal or combined scapholunate capsulodesis in the management of scapholunate ligament injuries. All patients will be assessed preoperatively by careful history taking , full general and local examination and radiological evaluation using wrist plain X-rays (Standard PA, clenched-fist PA , PA in ulnar deviation , lateral projection in neutral ,flexion and extension ) and wrist Magnetic resonance imaging.an informed written consent was taken before any surgery. The procedure starts with a standard radiocarpal and then midcarpal arthroscopy. During the arthroscopic examination ,several factors are assessed, including the location of the SLIL injury (volar, membranous, dorsal, or complete), the condition of the cartilage, the reducibility of the carpus, and other associated pathologies like TFCC injury. Classification is done using Geissler Classification, Garcia Elias Classification and EWAS classification.Volar capsulodesis using Hayman Lui et al or Del Pinal et al method and/or dorsal capsulodesis using original Mathoulin technique or combined capsulodesis were done.
- Conditions
- Scapholunate Interosseous Ligament Injury, SLLI
- Being tested
- arthroscopic assisted volar scapholunate capsulodesis, arthroscopic assisted dorsal scapholunate capsulodesis, arthroscopic assisted combined volar and dorsal scapholunate capsulodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic assisted volar scapholunate capsulodesisProcedure or surgery
Also called volar scapholunate capsuloligamentodesis
arthroscopic assisted volar scapholunate capsulodesis using PDS 2.00 sutures
arthroscopic assisted dorsal scapholunate capsulodesisProcedure or surgery
arthroscopic assisted dorsal scapholunate capsulodesis using PDS 2.00 sutures
arthroscopic assisted combined volar and dorsal scapholunate capsulodesisProcedure or surgery
arthroscopic assisted combined volar and dorsal scapholunate capsulodesis using PDS 2.00 sutures
| Study group | Role | What they receive |
|---|---|---|
| arthroscopic assisted volar scapholunate capsulodesis | Other | arthroscopic assisted combined volar capsulodesis using PDS 2.00 sutures Receives: Procedure: arthroscopic assisted volar scapholunate capsulodesis; Procedure: arthroscopic assisted dorsal scapholunate capsulodesis; Procedure: arthroscopic assisted combined volar and dorsal scapholunate capsulodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
wrist range of motion
wrist range of motion degrees in flexion , extension, radial deviation and ulnar deviation.
Measured: preoperative and postoperative after 3months , 6months , 9months and 12months
Secondary outcomes (1)
scapholunate gap
scapholunate gap in PA wrist plain Xray is the distance between middle of scaphoid and middle of lunate bones in PA wrist plain Xray in millimeters
Measured: preoperative and postoperative scapholunate gaps after 3months , 6months , 9months and 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start15 Mar 2023
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapholunate Interosseous Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925230
- Sponsor's protocol ID
- MD 61/2023
- Acronym
- case series
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 13 Apr 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 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Assisted Volar, Dorsal or Combined Capsulodesis in Scapholunate Ligament Injury
- ClinicalTrials.gov ID
- NCT06925230
- Acronym / sponsor ID
- case series / MD 61/2023
- Conditions
- Scapholunate Interosseous Ligament Injury, SLLI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 13 Apr 2025 (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.
The aim of this case series study is to test the efficacy of arthroscopic assisted volar, dorsal or combined scapholunate capsulodesis in the management of scapholunate ligament injuries.
Detailed description
The aim of this case series study is to test the efficacy of arthroscopic assisted volar, dorsal or combined scapholunate capsulodesis in the management of scapholunate ligament injuries. All patients will be assessed preoperatively by careful history taking , full general and local examination and radiological evaluation using wrist plain X-rays (Standard PA, clenched-fist PA , PA in ulnar deviation , lateral projection in neutral ,flexion and extension ) and wrist Magnetic resonance imaging.an informed written consent was taken before any surgery. The procedure starts with a standard radiocarpal and then midcarpal arthroscopy. During the arthroscopic examination ,several factors are assessed, including the location of the SLIL injury (volar, membranous, dorsal, or complete), the condition of the cartilage, the reducibility of the carpus, and other associated pathologies like TFCC injury. Classification is done using Geissler Classification, Garcia Elias Classification and EWAS classification.Volar capsulodesis using Hayman Lui et al or Del Pinal et al method and/or dorsal capsulodesis using original Mathoulin technique or combined capsulodesis were done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arthroscopic assisted volar scapholunate capsulodesis | Other | Procedure: arthroscopic assisted volar scapholunate capsulodesis, Procedure: arthroscopic assisted dorsal scapholunate capsulodesis, Procedure: arthroscopic assisted combined volar and dorsal scapholunate capsulodesisarthroscopic assisted combined volar capsulodesis using PDS 2.00 sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sex: both sexes.
- Age: above 18 years
- Lesion: subacute or chronic scapholunate ligament injury
- partial and complete SLIL tears
Key exclusion criteria (4 listed)
- Acute scapholunate ligament injury
- irreducible carpal malalignment
- posttraumatic arthritis
- associated fractures that could affect the functional outcome
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 assisted volar scapholunate capsulodesisAlso: volar scapholunate capsuloligamentodesisarthroscopic assisted volar scapholunate capsulodesis using PDS 2.00 sutures | Procedure or surgery | arthroscopic assisted volar scapholunate capsulodesis |
| arthroscopic assisted dorsal scapholunate capsulodesisarthroscopic assisted dorsal scapholunate capsulodesis using PDS 2.00 sutures | Procedure or surgery | arthroscopic assisted volar scapholunate capsulodesis |
| arthroscopic assisted combined volar and dorsal scapholunate capsulodesisarthroscopic assisted combined volar and dorsal scapholunate capsulodesis using PDS 2.00 sutures | Procedure or surgery | arthroscopic assisted volar scapholunate capsulodesis |
Primary outcome
wrist range of motion
Time frame: preoperative and postoperative after 3months , 6months , 9months and 12months
wrist range of motion degrees in flexion , extension, radial deviation and ulnar deviation.
1 secondary outcome
scapholunate gap
Time frame: preoperative and postoperative scapholunate gaps after 3months , 6months , 9months and 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
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Active, not recruitingObservational study
Comparison of Strength, Weight Bearing, Proprioception, Reaction Time and Function in Scapholunate Instability
Scapholunate Interosseous Ligament Injury, Scaphoid-Lunate Instability
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.
The record lists no contact. Use the official record to reach the sponsor.
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 assisted volar scapholunate capsulodesis, arthroscopic assisted dorsal scapholunate capsulodesis and arthroscopic assisted combined volar and dorsal scapholunate capsulodesis in people with Scapholunate Interosseous Ligament Injury and SLLI, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Apr 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wrist range of motion (time frame: preoperative and postoperative after 3months , 6months , 9months and 12months). 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 13 Apr 2025.