Danish Multicenter Scapholunate Ligament Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Aarhus
About this trial
Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Berger
Procedure/SurgeryTreatment 1
3LT
Procedure/SurgeryTreatment 2
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: BergerActive comparator 1 intervention
Group B: 3LTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
points
Time frame
At all follow-ups (0-10 years)Secondary outcomes
1
Grip-strength
kg
Time frame
At all follow-ups (0-10 years)2
SL angle
degrees
Time frame
At all follow-ups (0-10 years)3
The Patient-Rated Wrist Evaluation (PRWE) score
points
Time frame
At all follow-ups (0-10 years)4
Wrist motion
degrees
Time frame
At all follow-ups (0-10 years)Sponsors and contacts
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Source ClinicalTrials.gov