Ligament Injury, Wrist Sprain
Conditions
Brief summary
Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.
Detailed description
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.
Interventions
PROCEDUREBerger
Treatment 1
PROCEDURE3LT
Treatment 2
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Scares are identical. Patient and examiner are blinded
Intervention model description
randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | At all follow-ups (0-10 years) | points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip-strength | At all follow-ups (0-10 years) | kg |
| SL angle | At all follow-ups (0-10 years) | degrees |
| The Patient-Rated Wrist Evaluation (PRWE) score | At all follow-ups (0-10 years) | points |
| Wrist motion | At all follow-ups (0-10 years) | degrees |
Countries
Denmark
Contacts
Primary ContactJanni K Thillemann, Dr
Outcome results
None listed