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Clinical Trials in Denmark / NCT04348253
Recruiting Not applicable

Danish Multicenter Scapholunate Ligament Study

NCT04348253 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2018-08-01
Last updated
2020-04-16

Condition(s) studied

Ligament InjuryWrist Sprain

Investigational drug(s) / intervention(s)

Berger3LT

Berger: Treatment 1

3LT: Treatment 2

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark Recruiting
Hospital Unit Vest Holstebro Denmark Recruiting

More University of Aarhus trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04348253 on ClinicalTrials.gov ↗ ← All trials in Denmark