Comparing two surgical techniques for wrist ligament reconstruction
Official title: Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)
Run by University of Aarhus · NCT04348253 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus and 1 other locations) |
| Status | Recruiting |
| Started | August 1, 2018 |
| Main results expected | April 30, 2023 |
| Study ends | April 30, 2033 |
| Registry record updated | April 16, 2020 |
| Trial ID | NCT04348253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-60 with symptomatic SL instability and confirmed complete SL ligament lesions.
✕Probably not a fit
Patients with less severe SL injuries or those with additional wrist complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown varying success with different surgical techniques for ligament reconstruction, making this a relevant comparison in the field.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.