RecruitingNot ApplicableNCT04348253
Danish Multicenter Scapholunate Ligament Study
Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)
Sponsor
University of Aarhus
Enrollment
100 participants
Start Date
Aug 1, 2018
Study Type
INTERVENTIONAL
Conditions
Summary
Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.
Eligibility
Min Age: 18 YearsMax Age: 60 Years
Inclusion Criteria5
- 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 Criteria8
- 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.
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Interventions
PROCEDUREBerger
Treatment 1
PROCEDURE3LT
Treatment 2
Locations(2)
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NCT04348253
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