Status:

RECRUITING

Danish Multicenter Scapholunate Ligament Study

Lead Sponsor:

University of Aarhus

Conditions:

Ligament Injury

Wrist Sprain

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2033

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04348253

Start Date

August 1 2018

End Date

April 30 2033

Last Update

April 16 2020

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Aarhus University Hospital

Aarhus, Denmark, 8200

2

Hospital Unit Vest

Holstebro, Denmark, 7500