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)

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

Study Overview

• Status: Recruiting
• Conditions: Ligament Injury; Wrist Sprain
• Intervention / Treatment: Procedure: Berger; Procedure: 3LT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janni K Thillemann, Dr; Phone Number: +45 28137303; Email: teamjanni@gmail.com

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Maiken Stilling, Professor
  • Holstebro, Denmark, 7500
    • Recruiting
    • Hospital Unit Vest
    • Contact: Janni K Thillemann, Dr; Phone Number: +4528137303; Email: teamjanni@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Berger; Bergers capsulodesis	Procedure: Berger; Treatment 1
ACTIVE_COMPARATOR: 3LT; Three ligament tenodesis	Procedure: 3LT; Treatment 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)	points	At all follow-ups (0-10 years)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Janni K Thillemann, Dr, Hospitalsenheden Vest

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ANTICIPATED): April 30, 2023
• Study Completion (ANTICIPATED): April 30, 2033

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1-10-72-169-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No