Comparison of Arthroscopic Debridement and Arthroscopic Hemi-Trapeziectomy With Mini TightRope on Patients With Thumb Carpometacarpal Joint Osteoarthritis - A Prospective Randomized Single-Blinded Controlled Trial
Overview
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Kapandji Score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes assessor and biostatistician will be blinded
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Kapandji Score
Time Frame: Post-op 24 months
A tool for assessing the opposition of the thumb
Key and Tip Pinch
Time Frame: Post-op 24 months
Will be measured in kg
Range of Motion (ROM)
Time Frame: Post-op 24 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Complications
Time Frame: Post-operative up to 2 years
Any complications related to the surgery will be documented
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time Frame: Post-op 24 months
Specially designed tool to assess upper extremity disability and symptoms
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Time Frame: Post-op 24 months
VAS pain score at rest and exertion will be measured post-operatively
Short-Form Survey (SF-36)
Time Frame: Post-op 24 months
Generic health status instrument to assess quality of life
Patients' Satisfaction Score
Time Frame: Post-op 24 months
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Grip Strength
Time Frame: Post-op 24 months
Will be measured in kg
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael Chu Kay MAK
Associate Consultant and Clinical Assistant Professor (Honorary)
Chinese University of Hong Kong