Comparing two surgical techniques for wrist ligament reconstruction
Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)
This study is testing which of two surgical methods works better for people with wrist ligament problems to help them feel better in the long run.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus and 1 other locations) |
| Trial ID | NCT04348253 on ClinicalTrials.gov |
What this trial studies
This multicenter study aims to compare two surgical techniques commonly used for the reconstruction of the scapholunate (SL) ligament. Participants with symptomatic SL instability will be randomized to receive either the Berger technique or the 3LT technique. The study will evaluate patient-reported outcomes, clinical assessments, and radiological results up to 10 years post-treatment. The goal is to determine which surgical approach yields better long-term outcomes for patients with complete SL ligament lesions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with symptomatic SL instability and confirmed complete SL ligament lesions.
Not a fit: Patients with less severe SL injuries or those with additional wrist complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques for treating wrist ligament injuries, enhancing recovery and quality of life for patients.
How similar studies have performed: Previous studies have shown varying success with different surgical techniques for ligament reconstruction, making this a relevant comparison in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-60 years (both included). * Symptomatic SL instability (VAS score ³3, QDASH score ³ 20). * \> 6 weeks since symptomatic hand trauma (chronic SL lesions). * SL gapping on radiographic stress views or SL gapping (³2mm) on static PA views. * Complete SL ligament lesion confirmed by wrist arthroscopy Exclusion Criteria: * Geissler grade 1-3 SLL injury (evaluated by arthroscopy). * Concomitant complete luno-triquetral (LT) ligament injury (evaluated by arthroscopy). * Lesion of TFCC leading to DRUJ instability (evaluated by arthroscopy). * Radiocarpal or midcarpal arthritis evaluated by arthroscopy. * Previous fracture in carpus or intraarticular radius fracture with step off (³2 mm), disposing to posttraumatic arthritis. * Adverse effects after extra articular radial fractures (dorsal angulation ³10 grader). * Peroperatively non-reducible scaphoid flexion/SL gap. * Terminal illness or severe medical illness: ASA score higher than or equal to 3.
Where this trial is running
Aarhus and 1 other locations
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Hospital Unit Vest — Holstebro, Denmark (Recruiting)
Study contacts
- Principal investigator: Janni K Thillemann, Dr — Hospitalsenheden Vest
- Study coordinator: Janni K Thillemann, Dr
- Email: teamjanni@gmail.com
- Phone: +45 28137303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.