Arthroscopic Scapholunate Ligament Reconstruction

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Scapholunate Dissociation
• Intervention / Treatment: Procedure: Arthroscopic Scapholunate Ligament Reconstruction

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: chul ki goorens, MD; Phone Number: 0032478907124; Email: cgoorens@msn.com

Study Locations

• Belgium
  • Tienen, Belgium, 3300
    • Department of orthopaedics RZ Tienen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
passive and active range of motion (degrees) operated and contralateral side	flexion, extension, ulnar and radial deviation	preop
passive and active range of motion (degrees) operated and contralateral side	flexion, extension, ulnar and radial deviation	postoperative 3 months
passive and active range of motion (degrees) operated and contralateral side	flexion, extension, ulnar and radial deviation	postoperative 6 months
passive and active range of motion (degrees) operated and contralateral side	flexion, extension, ulnar and radial deviation	postoperative 12 months
grip strength (kg) operated and contralateral side	dynamometer (kg)	preop
grip strength (kg) operated and contralateral side	dynamometer (kg)	postoperative 3 months
grip strength (kg) operated and contralateral side	dynamometer (kg)	postoperative 6 months
grip strength (kg) operated and contralateral side	dynamometer (kg)	postoperative 12 months
pain (visual analogue scale)	Visual analogue Scale (0 no pain -10 cm worst pain)	preop
pain (visual analogue scale)	Visual analogue Scale Scale (0 no pain -10 cm worst pain)	postoperative 3 months
pain (visual analogue scale)	Visual analogue Scale Scale (0 no pain -10 cm worst pain)	postoperative 6 months
pain (visual analogue scale)	Visual analogue Scale (0 no pain -10 cm worst pain)	postoperative 12 months
Disabilities of the Arm, Shoulder and Hand score	function score (0 is best -100 is worst)	preop
Disabilities of the Arm, Shoulder and Hand score	function score (0 is best -100 is worst)	postoperative 3 months
Disabilities of the Arm, Shoulder and Hand score	function score (0 is best -100 is worst)	postoperative 6 months
Disabilities of the Arm, Shoulder and Hand score	function score (0 is best -100 is worst)	postoperative 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Regionaal Ziekenhuis Heilig Hart Tienen
• Investigators: Study Chair: Kjell Van Royen, MD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: reconstruction; scapholunate instability
• Additional Relevant MeSH Terms: Mental Disorders; Dissociative Disorders
• Other Study ID Numbers: RZ Tienen EC 109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No