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)
1 other identifier
interventional
100
1 country
2
Brief Summary
Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 30, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2033
ExpectedApril 16, 2020
March 1, 2020
4.7 years
March 30, 2020
April 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
points
At all follow-ups (0-10 years)
Secondary Outcomes (4)
Grip-strength
At all follow-ups (0-10 years)
SL angle
At all follow-ups (0-10 years)
The Patient-Rated Wrist Evaluation (PRWE) score
At all follow-ups (0-10 years)
Wrist motion
At all follow-ups (0-10 years)
Study Arms (2)
Berger
ACTIVE COMPARATORBergers capsulodesis
3LT
ACTIVE COMPARATORThree ligament tenodesis
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aarhus University Hospital
Aarhus, 8200, Denmark
Hospital Unit Vest
Holstebro, 7500, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Janni K Thillemann, Dr
Hospitalsenheden Vest
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Scares are identical. Patient and examiner are blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2020
First Posted
April 16, 2020
Study Start
August 1, 2018
Primary Completion
April 30, 2023
Study Completion (Estimated)
April 30, 2033
Last Updated
April 16, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share