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Recruiting NCT04348253

Danish Multicenter Scapholunate Ligament Study

No phase Interventional Ligament Injury Wrist Sprain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Berger, 3LT.
Who it may be relevant to
Registry conditions: Ligament Injury, Wrist Sprain. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)

Overview

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

Detailed description

This multicentre study aim to compare two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. The investigators compare patient reported, clinical and radiological outcomes up to 10 years after treatment of complete dynamic or static but reducible SL ligament lesions. The participants are randomized to two treatments. Effect parameters before and after intervention are compared between groups.

Interventions

  • Procedure Berger
    Treatment 1
  • Procedure 3LT
    Treatment 2

Primary outcome measures

  • The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) [Time frame: At all follow-ups (0-10 years)]
Secondary outcome measures (4)
  • Grip-strength [Time frame: At all follow-ups (0-10 years)]
  • SL angle [Time frame: At all follow-ups (0-10 years)]
  • The Patient-Rated Wrist Evaluation (PRWE) score [Time frame: At all follow-ups (0-10 years)]
  • Wrist motion [Time frame: At all follow-ups (0-10 years)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Denmark · 2 centers
  • Aarhus University Hospital — Aarhus
  • Hospital Unit Vest — Holstebro

Identifiers

NCT: NCT04348253 · 1-10-72-169-18

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗