- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06925230
Arthroscopic Assisted Volar, Dorsal or Combined Capsulodesis in Scapholunate Ligament Injury. (case series)
April 6, 2025 updated by: Ain Shams University
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Abbassia
-
Cairo, Abbassia, Egypt, 00000
- Ain Shams University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Sex: both sexes.
- Age: above 18 years
- Lesion: subacute or chronic scapholunate ligament injury
- partial and complete SLIL tears
Exclusion Criteria:
- Acute scapholunate ligament injury
- irreducible carpal malalignment
- posttraumatic arthritis
- associated fractures that could affect the functional outcome
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: arthroscopic assisted volar scapholunate capsulodesis
arthroscopic assisted combined volar capsulodesis using PDS 2.00 sutures
|
arthroscopic assisted volar scapholunate capsulodesis using PDS 2.00 sutures
Other Names:
arthroscopic assisted dorsal scapholunate capsulodesis using PDS 2.00 sutures
arthroscopic assisted combined volar and dorsal scapholunate capsulodesis using PDS 2.00 sutures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
preoperative and postoperative after 3months , 6months , 9months and 12months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
scapholunate gap
Time Frame: preoperative and postoperative scapholunate gaps after 3months , 6months , 9months and 12months
|
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
|
preoperative and postoperative scapholunate gaps after 3months , 6months , 9months and 12months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2023
Primary Completion (Actual)
March 10, 2025
Study Completion (Actual)
March 10, 2025
Study Registration Dates
First Submitted
April 6, 2025
First Submitted That Met QC Criteria
April 6, 2025
First Posted (Actual)
April 13, 2025
Study Record Updates
Last Update Posted (Actual)
April 13, 2025
Last Update Submitted That Met QC Criteria
April 6, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD 61/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Scapholunate Interosseous Ligament Injury
-
Kristin Zhao, PhDNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedScapholunate Interosseous Ligament InjuryUnited States
-
Hacettepe UniversityCompletedScapholunate Dissociation | Scapholunate Interosseous Ligament Injury | Scaphoid-Lunate InstabilityTurkey
-
State University of New York - Upstate Medical...National Institutes of Health (NIH)CompletedScapholunate Interosseous Ligament | Torn Wrist LigamentsUnited States
-
Hacettepe Universityİstanbul Yeni Yüzyıl ÜniversitesiActive, not recruitingScapholunate Dissociation | Scapholunate Interosseous Ligament Injury | Scaphoid-Lunate InstabilityTurkey
-
Massachusetts General HospitalTerminatedScapholunate Ligament Tear
-
Istanbul Medipol University HospitalCompletedScapholunate Ligament Partial TearsTurkey
-
University of CalgaryAcumed, LLCNot yet recruitingScapholunate Dissociation | Complete Tear of Scapholunate Ligament
-
Acumed, LLCTerminatedAcute Scapholunate Injury
-
University Hospital DubravaArthrex GmbHNot yet recruitingCruciate Ligament Rupture | Cruciate Ligament Reconstruction | Cruciate Ligament Injury
-
Cedars-Sinai Medical CenterNot yet recruitingWrist Injuries | Hand Injuries | Ligament Rupture | Ligament Injury | Ligament AvulsionUnited States
Clinical Trials on arthroscopic assisted volar scapholunate capsulodesis
-
Regionaal Ziekenhuis Heilig Hart TienenNot yet recruiting
-
Cairo UniversityCompletedDevelopmental Dysplasia of the HipEgypt
-
Chunyan JiangStar Sports Medicine Co., LtdNot yet recruitingAnterior Cruciate Ligament
-
Second Affiliated Hospital of Wenzhou Medical UniversityUnknownTibial Fractures | Arthroscopy | Orthopedic | Fracture Fixation
-
Indonesia UniversityCompletedAnterior Cruciate Ligament Rupture | Sports Injury
-
Ludwig-Maximilians - University of MunichUnknown
-
Kasr El Aini HospitalCompleted
-
Beijing Jishuitan HospitalNot yet recruitingDislocation of the Acromioclavicular Joint
-
Spectrum Health HospitalsWithdrawnAnkle FracturesUnited States
-
Gazi UniversityActive, not recruitingMassive Irreparable Rotator Cuff TearsTurkey (Türkiye)