Arthroscopic Scapholunate Ligament Reconstruction

Scapholunate Dissociation Clinical Trial

Official title:

Arthroscopic Scapholunate Ligament Reconstruction, Volar and Dorsal Reconstruction, as Treatment for Dysfunction of the Scapholunate Joint With Insufficiency of the Scapholunate Ligament and Secondary Stabilizers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06236204
• Other study ID #: RZ Tienen EC 109
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Regionaal Ziekenhuis Heilig Hart Tienen
• Contact: chul ki goorens, MD
• Phone: 0032478907124
• Email: cgoorens[@]msn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Scapholunate Dissociation

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	Department of orthopaedics RZ Tienen	Tienen

Sponsors (1)

Lead Sponsor	Collaborator
Regionaal Ziekenhuis Heilig Hart Tienen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	passive and active range of motion (degrees) operated and contralateral side	flexion, extension, ulnar and radial deviation	preop
Primary	passive and active range of motion (degrees) operated and contralateral side	flexion, extension, ulnar and radial deviation	postoperative 3 months
Primary	passive and active range of motion (degrees) operated and contralateral side	flexion, extension, ulnar and radial deviation	postoperative 6 months
Primary	passive and active range of motion (degrees) operated and contralateral side	flexion, extension, ulnar and radial deviation	postoperative 12 months
Primary	grip strength (kg) operated and contralateral side	dynamometer (kg)	preop
Primary	grip strength (kg) operated and contralateral side	dynamometer (kg)	postoperative 3 months
Primary	grip strength (kg) operated and contralateral side	dynamometer (kg)	postoperative 6 months
Primary	grip strength (kg) operated and contralateral side	dynamometer (kg)	postoperative 12 months
Primary	pain (visual analogue scale)	Visual analogue Scale (0 no pain -10 cm worst pain)	preop
Primary	pain (visual analogue scale)	Visual analogue Scale Scale (0 no pain -10 cm worst pain)	postoperative 3 months
Primary	pain (visual analogue scale)	Visual analogue Scale Scale (0 no pain -10 cm worst pain)	postoperative 6 months
Primary	pain (visual analogue scale)	Visual analogue Scale (0 no pain -10 cm worst pain)	postoperative 12 months
Primary	Disabilities of the Arm, Shoulder and Hand score	function score (0 is best -100 is worst)	preop
Primary	Disabilities of the Arm, Shoulder and Hand score	function score (0 is best -100 is worst)	postoperative 3 months
Primary	Disabilities of the Arm, Shoulder and Hand score	function score (0 is best -100 is worst)	postoperative 6 months
Primary	Disabilities of the Arm, Shoulder and Hand score	function score (0 is best -100 is worst)	postoperative 12 months
Secondary	patient satisfaction after treatment	visual analogue scale (0 is worst -10 cm is best)	postoperative 12 months
Secondary	complications	descriptive	postoperative 12 months
Secondary	arthroscopical assessment of the scapholunate stability	according to European Wrist Arthroscopy Society classification (EWAS1 best -5 worst)	intraoperative
Secondary	scapholunate distance, carpal angles	radiological follow-up (distance in mm or angles in degrees)	preop
Secondary	scapholunate distance, carpal angles	radiological follow-up (distance in mm or angles in degrees)	postoperative 12 months