Danish Multicenter Scapholunate Ligament Study

Study Overview
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Brief Summary
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Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.

Detailed Description
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This multicentre study aim to compare two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. The investigators compare patient reported, clinical and radiological outcomes up to 10 years after treatment of complete dynamic or static but reducible SL ligament lesions. The participants are randomized to two treatments. Effect parameters before and after intervention are compared between groups.

Official Title
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Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)

Conditions
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Ligament Injury, Wrist Sprain

Intervention / Treatment
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* Procedure: Berger
* Procedure: 3LT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Berger<br>Bergers capsulodesis | Procedure: Berger<br>* Treatment 1<br>|
| Active Comparator: 3LT<br>Three ligament tenodesis | Procedure: 3LT<br>* Treatment 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | points | At all follow-ups (0-10 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip-strength | kg | At all follow-ups (0-10 years) | 
| SL angle | degrees | At all follow-ups (0-10 years) | 
| The Patient-Rated Wrist Evaluation (PRWE) score | points | At all follow-ups (0-10 years) | 
| Wrist motion | degrees | At all follow-ups (0-10 years) |