Clinical trial NCT04217928: Arthroscopic Debridement vs Arthroscopic Hemi-Trapeziectomy on Patients With Thumb Carpometacarpal Joint Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis Thumb
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
timeFrame: Pre-operative
measure: Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
timeFrame: Post-op 3 months
measure: Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
timeFrame: Post-op 6 months
measure: Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
timeFrame: Post-op 12 months
measure: Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
timeFrame: Post-op 24 months
measure: Short-Form Survey (SF-36)
timeFrame: Pre-operative
measure: Short-Form Survey (SF-36)
timeFrame: Post-op 3 months
measure: Short-Form Survey (SF-36)
timeFrame: Post-op 6 months
measure: Short-Form Survey (SF-36)
timeFrame: Post-op 12 months
measure: Short-Form Survey (SF-36)
timeFrame: Post-op 24 months
measure: Disability of Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Pre-operative
measure: Disability of Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Post-op 3 months
measure: Disability of Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Post-op 6 months
measure: Disability of Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Post-op 12 months
measure: Disability of Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Post-op 24 months
measure: Patients' Satisfaction Score
timeFrame: Pre-operative
measure: Patients' Satisfaction Score
timeFrame: Post-op 3 months
measure: Patients' Satisfaction Score
timeFrame: Post-op 6 months
measure: Patients' Satisfaction Score
timeFrame: Post-op 12 months
measure: Patients' Satisfaction Score
timeFrame: Post-op 24 months
measure: Grip Strength
timeFrame: Pre-operative
measure: Grip Strength
timeFrame: Post-op 3 months
measure: Grip Strength
timeFrame: Post-op 6 months
measure: Grip Strength
timeFrame: Post-op 12 months
measure: Grip Strength
timeFrame: Post-op 24 months
measure: Key and Tip Pinch
timeFrame: Pre-operative
measure: Key and Tip Pinch
timeFrame: Post-op 3 months
measure: Key and Tip Pinch
timeFrame: Post-op 6 months
measure: Key and Tip Pinch
timeFrame: Post-op 12 months
measure: Key and Tip Pinch
timeFrame: Post-op 24 months
measure: Range of Motion (ROM)
timeFrame: Pre-operative
measure: Range of Motion (ROM)
timeFrame: Post-op 3 months
measure: Range of Motion (ROM)
timeFrame: Post-op 6 months
measure: Range of Motion (ROM)
timeFrame: Post-op 12 months
measure: Range of Motion (ROM)
timeFrame: Post-op 24 months
measure: Kapandji Score
timeFrame: Pre-operative
measure: Kapandji Score
timeFrame: Post-op 3 months
measure: Kapandji Score
timeFrame: Post-op 6 months
measure: Kapandji Score
timeFrame: Post-op 12 months
measure: Kapandji Score
timeFrame: Post-op 24 months
measure: Complications
timeFrame: Post-operative up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: