Danish Multicenter Scapholunate Ligament Study

University of Aarhus

Status: Enrolling

Conditions: Wrist Sprain; Ligament Injury

Treatments: Procedure: 3LT; Procedure: Berger

Study type: Interventional

Funder types: Other

Identifiers

NCT04348253

1-10-72-169-18

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Berger

Active Comparator group

Description:

Bergers capsulodesis

Treatment:

Procedure: Berger

3LT

Active Comparator group

Description:

Three ligament tenodesis

Treatment:

Procedure: 3LT