Danish Multicenter Scapholunate Ligament Study

Not Applicable

Recruiting

• Conditions: Wrist Sprain; Ligament Injury
• Interventions: Procedure: Berger; Procedure: 3LT

• Registration Number: NCT04348253
• Lead Sponsor: University of Aarhus

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-15
• Last Update Submitted: 2020-04-15
• Study First Posted: 2020-04-16
• Last Update Posted: 2020-04-16
• Primary Completion: 2023-04-30
• Study Completion: 2033-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Berger	Berger	Bergers capsulodesis
3LT	3LT	Three ligament tenodesis

Primary Outcome Measures

Name	Time	Method
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)	At all follow-ups (0-10 years)	points

Secondary Outcome Measures

Name	Time	Method
Wrist motion	At all follow-ups (0-10 years)	degrees
Grip-strength	At all follow-ups (0-10 years)	kg
SL angle	At all follow-ups (0-10 years)	degrees
The Patient-Rated Wrist Evaluation (PRWE) score	At all follow-ups (0-10 years)	points

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Hospital Unit Vest; 🇩🇰 Holstebro, Denmark