Clinical trial NCT06236204: Arthroscopic Scapholunate Ligament Reconstruction
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Scapholunate Dissociation
Keywords: scapholunate instability
reconstruction
Lead sponsor: Regionaal Ziekenhuis Heilig Hart Tienen
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective single center - single surgeon
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: passive and active range of motion (degrees) operated and contralateral side
timeFrame: preop
measure: passive and active range of motion (degrees) operated and contralateral side
timeFrame: postoperative 3 months
measure: passive and active range of motion (degrees) operated and contralateral side
timeFrame: postoperative 6 months
measure: passive and active range of motion (degrees) operated and contralateral side
timeFrame: postoperative 12 months
measure: grip strength (kg) operated and contralateral side
timeFrame: preop
measure: grip strength (kg) operated and contralateral side
timeFrame: postoperative 3 months
measure: grip strength (kg) operated and contralateral side
timeFrame: postoperative 6 months
measure: grip strength (kg) operated and contralateral side
timeFrame: postoperative 12 months
measure: pain (visual analogue scale)
timeFrame: preop
measure: pain (visual analogue scale)
timeFrame: postoperative 3 months
measure: pain (visual analogue scale)
timeFrame: postoperative 6 months
measure: pain (visual analogue scale)
timeFrame: postoperative 12 months
measure: Disabilities of the Arm, Shoulder and Hand score
timeFrame: preop
measure: Disabilities of the Arm, Shoulder and Hand score
timeFrame: postoperative 3 months
measure: Disabilities of the Arm, Shoulder and Hand score
timeFrame: postoperative 6 months
measure: Disabilities of the Arm, Shoulder and Hand score
timeFrame: postoperative 12 months
Secondary outcomes:
measure: patient satisfaction after treatment
timeFrame: postoperative 12 months
measure: complications
timeFrame: postoperative 12 months
measure: arthroscopical assessment of the scapholunate stability
timeFrame: intraoperative
measure: scapholunate distance, carpal angles
timeFrame: preop
measure: scapholunate distance, carpal angles
timeFrame: postoperative 12 months
Other outcomes:
Locations:
city: Tienen
country: Belgium
facility: Department of orthopaedics RZ Tienen
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Kjell Van Royen, MD
role: STUDY_CHAIR
References: