Arthroscopic Scapholunate Ligament Reconstruction

NCT06236204 | Unknown

• 1 other identifier: RZ Tienen EC 109
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Scapholunate Dissociation

Keywords

scapholunate instability; reconstruction

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (5)

• patient satisfaction after treatment

  postoperative 12 months

• complications

  postoperative 12 months

• arthroscopical assessment of the scapholunate stability

  intraoperative

• scapholunate distance, carpal angles

  preop

• scapholunate distance, carpal angles

  postoperative 12 months

Study Arms (1)

Arthroscopic Scapholunate Ligament Reconstruction

EXPERIMENTAL

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

Interventions

Arthroscopic Scapholunate Ligament Reconstruction PROCEDURE

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

Arthroscopic Scapholunate Ligament Reconstruction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Regionaal Ziekenhuis Heilig Hart Tienen: lead

Study Sites (1)

Department of orthopaedics RZ Tienen

Tienen, 3300, Belgium

Location

Study Officials

• Kjell Van Royen, MD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

Central Study Contacts

chul ki goorens, MD

CONTACT

0032478907124; cgoorens@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthopaedic surgeon, principal investigator

Model Details: prospective single center - single surgeon

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

BE (1)