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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
Sponsor
University of Aarhus
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)

  • The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) — At all follow-ups (0-10 years)
    points

Trial sites (2)

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

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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