Arthroscopic Debridement vs Arthroscopic Hemi-Trapeziectomy on Patients With Thumb Carpometacarpal Joint Osteoarthritis

Not Applicable

• Conditions: Osteoarthritis Thumb

• Registration Number: NCT04217928
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Patients with thumb carpometacarpal joint osteoarthritis usually suffer from pain, joint enlargement, inflammation, deformity and loss of function. Conservative treatments usually are the first-line interventions, unfortunately some of the patients do not response to such treatments and surgical treatment will then be considered.

Compare to other traditional surgical techniques, arthroscopic techniques has resulted in the potential to treat osteoarthritis in a minimally invasive approach, avoiding the need for a larger incision. Other advantages of arthroscopy include less scarring and joint contracture, less risk of neurovascular injury, improved appearance, limited morbidity and quicker recovery. Although arthroscopic methods have been proved to be effective, there is lack of high-level evidence based studies to conclude one operation is superior to another. Hence, this study is designed to investigate outcomes of the two arthroscopic surgical methods (arthroscopic debridement vs arthroscopic hemi-trapeziectomy with Mini TightRope). The result of this study is expected to provide significant evidence based clinical data for surgeons worldwide on treating the thumb carpometacarpal joint osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-04
• Study Start: 2019-12-10
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-03
• Last Update Submitted: 2020-01-03
• Study First Posted: 2020-01-06
• Last Update Posted: 2020-01-06
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with Eaton and Glickel stage II and III of thumb carpometacarpal joint osteoarthritis
• Age≥18 years old
• Failed to response to nonsurgical/conservative treatments including orthoses/splinting, activity modification, oral analgesics (e.g. nonsteroidal anti-inflammatory drugs), strengthening/flexibility exercises, and injections of corticosteroid or hyaluronic acid
• Willing to receive surgery

Exclusion Criteria

• Patients received previous thumb surgery proximal to the interphalangeal joint (IPJ)
• Patients with prior traumatic thumb injuries (e.g. fracture, dislocation)
• Patients with significant metacarpophalangeal joint (MCPJ) pain
• With concurrent procedures on the thumb, e.g. ganglion removal, trigger thumb release

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Key and Tip Pinch	Post-op 24 months	Will be measured in kg
Range of Motion (ROM)	Post-op 24 months	ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Kapandji Score	Post-op 24 months	A tool for assessing the opposition of the thumb
Complications	Post-operative up to 2 years	Any complications related to the surgery will be documented
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion	Post-op 24 months	VAS pain score at rest and exertion will be measured post-operatively
Short-Form Survey (SF-36)	Post-op 24 months	Generic health status instrument to assess quality of life
Disability of Arm, Shoulder and Hand (DASH) questionnaire	Post-op 24 months	Specially designed tool to assess upper extremity disability and symptoms
Patients' Satisfaction Score	Post-op 24 months	To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Grip Strength	Post-op 24 months	Will be measured in kg

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong