Arthroscopic Scapholunate Ligament Reconstruction

NCT ID: NCT06236204

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2025-12-31

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.

Conditions

Scapholunate Dissociation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Arthroscopic Scapholunate Ligament Reconstruction

Intervention Type: PROCEDURE

reconstruction of the SL ligament with palmaris tendon graft tunneled through the scaphoid and lunate as described by Corella et al.

Interventions

Arthroscopic Scapholunate Ligament Reconstruction

reconstruction of the SL ligament with palmaris tendon graft tunneled through the scaphoid and lunate as described by Corella et al.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regionaal Ziekenhuis Heilig Hart Tienen

OTHER

Sponsor Role: lead

Responsible Party

Goorens Chul Ki

orthopaedic surgeon, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kjell Van Royen, MD

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Locations

Department of orthopaedics RZ Tienen

Tienen, , Belgium

Countries

Belgium

Central Contacts

chul ki goorens, MD

Role: CONTACT

cgoorens@msn.com

0032478907124

Other Identifiers

RZ Tienen EC 109

Identifier Type: -

Identifier Source: org_study_id