Actively Recruiting
Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis
Led by University of Aarhus · Updated on 2020-04-16
100
Participants Needed
2
Research Sites
521 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are comparing two surgical techniques commonly used to reconstruct the scapholunate (SL) ligament in the wrist. This randomized multicenter study focuses on patients with complete dynamic or static but reducible SL ligament injuries that are symptomatic and have persisted for more than six weeks. The goal is to evaluate patient-reported, clinical, and radiological outcomes over a long term, up to 10 years after treatment. Participants are randomly assigned to receive one of two surgical treatments: Berger capsulodesis or three ligament tenodesis (3LT). Both procedures aim to repair the SL ligament, and the study compares their effects on function and wrist stability. The treatments are performed and monitored under controlled conditions, with follow-ups scheduled regularly throughout the 10-year period. During the study, participants will undergo assessments including the Disabilities of the Arm, Shoulder and Hand Score (QuickDASH), grip strength measurements, SL angle evaluations, the Patient-Rated Wrist Evaluation (PRWE) score, and wrist motion analysis. These assessments occur at each follow-up visit from the start through 10 years post-treatment. The study also monitors safety and clinical progress, ensuring comprehensive data collection on recovery and wrist function.
CONDITIONS
Brief Title
Danish Multicenter Scapholunate Ligament Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-60 years (both included).
- Symptomatic scapholunate ligament instability with pain score (VAS) of 3 or more and QuickDASH score of 20 or more.
- Injury older than 6 weeks since symptomatic hand trauma (chronic lesions).
- Scapholunate gapping visible on radiographic stress views or gapping of 2 mm or more on static posteroanterior views.
- Complete scapholunate ligament tear confirmed by wrist arthroscopy.
You will not qualify if you...
- Geissler grade 1 to 3 scapholunate ligament injury as evaluated by arthroscopy.
- Complete injury of the luno-triquetral ligament evaluated by arthroscopy.
- Triangular fibrocartilage complex lesion causing distal radioulnar joint instability.
- Radiocarpal or midcarpal arthritis evaluated by arthroscopy.
- Previous carpal fracture or intraarticular radius fracture with step-off of 2 mm or more.
- Problems after extra-articular radial fractures with dorsal angulation of 10 degrees or more.
- Non-reducible scaphoid flexion or scapholunate gap found during surgery.
- Terminal or severe medical illness with ASA score 3 or higher.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single surgical procedure with immediate recovery period
Participants undergo surgical reconstruction using one of two techniques followed by immediate post-operative care.
1 visit (in-person) for surgery and initial post-operative care
Duration - Up to 10 years
Participants are monitored with patient reported, clinical and radiological assessments to evaluate outcomes after surgery.
Multiple follow-up visits over 10 years
Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
2
Hospital Unit Vest
Holstebro, Denmark, 7500
Actively Recruiting
Research Team
J
Janni K Thillemann, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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