Danish Multicenter Scapholunate Ligament Study

Ligament Injury Clinical Trial

Official title:

Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04348253
• Other study ID #: 1-10-72-169-18
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: April 30, 2033

Study information

• Verified date: March 2020
• Source: University of Aarhus
• Contact: Janni K Thillemann, Dr
• Phone: +45 28137303
• Email: teamjanni[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2033
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ligament Injury
• Sprains and Strains
• Wounds and Injuries
• Wrist Sprain

Intervention

Procedure:
• Berger
Treatment 1
• 3LT
Treatment 2

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Hospital Unit Vest	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)	points	At all follow-ups (0-10 years)
Secondary	Grip-strength	kg	At all follow-ups (0-10 years)
Secondary	SL angle	degrees	At all follow-ups (0-10 years)
Secondary	The Patient-Rated Wrist Evaluation (PRWE) score	points	At all follow-ups (0-10 years)
Secondary	Wrist motion	degrees	At all follow-ups (0-10 years)