Arthroscopic Scapholunate Ligament Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Scapholunate Dissociation
• Interventions: Procedure: Arthroscopic Scapholunate Ligament Reconstruction

• Registration Number: NCT06236204
• Lead Sponsor: Regionaal Ziekenhuis Heilig Hart Tienen

Brief Summary

Arthroscopical reconstruction of the volar and dorsal part of the scapholunate ligament as treatment for complete scapholunate ligament injury, but reducible carpal malalignment.

This prospective study aims to evaluate the clinical and functional outcome of this technique on the short and middle term

Detailed Description

Classical arthroscopic techniques for scapholunate instability consist of debridement, thermal shrinkage, and percutaneous pinning. Good results are obtained in acute lesions or in chronic partial tears, but they are less predictable when the lesion is complete, because of the poor healing capacity of the scapholunate ligament and because it is not possible to perform an anatomic ligamentous reconstruction with these techniques. Open techniques are thus required for reconstruction, but they damage the soft tissues. Corella et al. published a description and cadaver study of an arthroscopic ligamentoplasty, trying to combine the advantages of arthroscopic techniques (minimally invasive surgery) and open techniques (reconstruction of the ligament). With this approach, it is possible to reconstruct the dorsal scapholunate ligament and the secondary stabilizers while causing minimal damage to the soft tissues and avoiding injury to the posterior interosseous nerve and detachment of the dorsal intercarpal ligament. Arthroscopic scapholunate volar and dorsal ligament reconstruction achieves an anatomic reconstruction to provide a strong construct for early mobilization.

Study Timeline

• Study First Submitted: 2023-01-25
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study Start: 2024-02
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Scapholunate dysfunction, complete irrepairable lesion of the SL ligament and the secondary stabilizers (RSC-LRL-SRL) EWAS stage 4-5, no arthritis, with reducible malalignment
• 18 - 65 years

Exclusion Criteria

• • associated lesions, fractures
• neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arthroscopic Scapholunate Ligament Reconstruction	Arthroscopic Scapholunate Ligament Reconstruction	Experimental: patients with dynamic scapholunate instability wrist arthroscopy: bone-tendon reconstruction of the volar and dorsal part of the scapholunate complex

Primary Outcome Measures

Name	Time	Method
grip strength (kg) operated and contralateral side	postoperative 12 months	dynamometer (kg)
Disabilities of the Arm, Shoulder and Hand score	postoperative 12 months	function score (0 is best -100 is worst)
passive and active range of motion (degrees) operated and contralateral side	postoperative 12 months	flexion, extension, ulnar and radial deviation
pain (visual analogue scale)	postoperative 12 months	Visual analogue Scale (0 no pain -10 cm worst pain)

Secondary Outcome Measures

Name	Time	Method
patient satisfaction after treatment	postoperative 12 months	visual analogue scale (0 is worst -10 cm is best)
complications	postoperative 12 months	descriptive
scapholunate distance, carpal angles	postoperative 12 months	radiological follow-up (distance in mm or angles in degrees)
arthroscopical assessment of the scapholunate stability	intraoperative	according to European Wrist Arthroscopy Society classification (EWAS1 best -5 worst)

Trial Locations

Locations (1)

Department of orthopaedics RZ Tienen; 🇧🇪 Tienen, Belgium