Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID04348253

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

Led by University of Aarhus · Updated on 2020-04-16

100

Participants Needed

2

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two surgical techniques commonly used to reconstruct the scapholunate (SL) ligament in the wrist. This randomized multicenter study focuses on patients with complete dynamic or static but reducible SL ligament injuries that are symptomatic and have persisted for more than six weeks. The goal is to evaluate patient-reported, clinical, and radiological outcomes over a long term, up to 10 years after treatment. Participants are randomly assigned to receive one of two surgical treatments: Berger capsulodesis or three ligament tenodesis (3LT). Both procedures aim to repair the SL ligament, and the study compares their effects on function and wrist stability. The treatments are performed and monitored under controlled conditions, with follow-ups scheduled regularly throughout the 10-year period. During the study, participants will undergo assessments including the Disabilities of the Arm, Shoulder and Hand Score (QuickDASH), grip strength measurements, SL angle evaluations, the Patient-Rated Wrist Evaluation (PRWE) score, and wrist motion analysis. These assessments occur at each follow-up visit from the start through 10 years post-treatment. The study also monitors safety and clinical progress, ensuring comprehensive data collection on recovery and wrist function.

CONDITIONS

Brief Title

Danish Multicenter Scapholunate Ligament Study

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-60 years (both included).
  • Symptomatic scapholunate ligament instability with pain score (VAS) of 3 or more and QuickDASH score of 20 or more.
  • Injury older than 6 weeks since symptomatic hand trauma (chronic lesions).
  • Scapholunate gapping visible on radiographic stress views or gapping of 2 mm or more on static posteroanterior views.
  • Complete scapholunate ligament tear confirmed by wrist arthroscopy.
Not Eligible

You will not qualify if you...

  • Geissler grade 1 to 3 scapholunate ligament injury as evaluated by arthroscopy.
  • Complete injury of the luno-triquetral ligament evaluated by arthroscopy.
  • Triangular fibrocartilage complex lesion causing distal radioulnar joint instability.
  • Radiocarpal or midcarpal arthritis evaluated by arthroscopy.
  • Previous carpal fracture or intraarticular radius fracture with step-off of 2 mm or more.
  • Problems after extra-articular radial fractures with dorsal angulation of 10 degrees or more.
  • Non-reducible scaphoid flexion or scapholunate gap found during surgery.
  • Terminal or severe medical illness with ASA score 3 or higher.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Single surgical procedure with immediate recovery period

Participants undergo surgical reconstruction using one of two techniques followed by immediate post-operative care.

1 visit (in-person) for surgery and initial post-operative care

Post-operative Follow-up

Duration - Up to 10 years

Participants are monitored with patient reported, clinical and radiological assessments to evaluate outcomes after surgery.

Multiple follow-up visits over 10 years

Trial Site Locations

Total: 2 locations

1

Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

2

Hospital Unit Vest

Holstebro, Denmark, 7500

Actively Recruiting

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Research Team

J

Janni K Thillemann, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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