RecruitingNot ApplicableNCT04348253

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)


Sponsor

University of Aarhus

Enrollment

100 participants

Start Date

Aug 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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.

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Interventions

PROCEDUREBerger

Treatment 1

PROCEDURE3LT

Treatment 2


Locations(2)

Aarhus University Hospital

Aarhus, Denmark

Hospital Unit Vest

Holstebro, Denmark

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NCT04348253


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