Arthroscopic Debridement vs Arthroscopic Hemi-Trapeziectomy on Patients With Thumb Carpometacarpal Joint Osteoarthritis
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2019
CompletedStudy Start
First participant enrolled
December 10, 2019
CompletedFirst Posted
Study publicly available on registry
January 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 6, 2020
January 1, 2020
4.1 years
December 4, 2019
January 3, 2020
Conditions
Outcome Measures
Primary Outcomes (41)
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Pre-operative VAS pain score at rest and exertion will be measured
Pre-operative
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Post-op 3 months
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Post-op 6 months
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Post-op 12 months
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Post-op 24 months
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Pre-operative
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Post-op 3 months
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Post-op 6 months
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Post-op 12 months
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Post-op 24 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Pre-operative
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Post-op 3 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Post-op 6 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Post-op 12 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Post-op 24 months
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Pre-operative
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Post-op 3 months
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Post-op 6 months
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Post-op 12 months
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Post-op 24 months
Grip Strength
Will be measured in kg
Pre-operative
Grip Strength
Will be measured in kg
Post-op 3 months
Grip Strength
Will be measured in kg
Post-op 6 months
Grip Strength
Will be measured in kg
Post-op 12 months
Grip Strength
Will be measured in kg
Post-op 24 months
Key and Tip Pinch
Will be measured in kg
Pre-operative
Key and Tip Pinch
Will be measured in kg
Post-op 3 months
Key and Tip Pinch
Will be measured in kg
Post-op 6 months
Key and Tip Pinch
Will be measured in kg
Post-op 12 months
Key and Tip Pinch
Will be measured in kg
Post-op 24 months
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Pre-operative
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Post-op 3 months
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Post-op 6 months
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Post-op 12 months
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Post-op 24 months
Kapandji Score
A tool for assessing the opposition of the thumb
Pre-operative
Kapandji Score
A tool for assessing the opposition of the thumb
Post-op 3 months
Kapandji Score
A tool for assessing the opposition of the thumb
Post-op 6 months
Kapandji Score
A tool for assessing the opposition of the thumb
Post-op 12 months
Kapandji Score
A tool for assessing the opposition of the thumb
Post-op 24 months
Complications
Any complications related to the surgery will be documented
Post-operative up to 2 years
Study Arms (2)
Arthroscopic Debridement
ACTIVE COMPARATORPatients who are randomized into this arm will receive arthroscopic debridement
Arthroscopic Hemi-Trapeziectomy with Mini TightRope
ACTIVE COMPARATORPatients who are randomized into this arm will receive arthroscopic hemi-trapeziectomy with mini tightrope
Interventions
Arthroscopic debridement will be performed under portal site local anaesthesia.
Anaesthesia, position and arthroscopy will be performed in the same way as for arthroscopic debridement, except the distal part of the trapezium will be resected to a depth of 3-4mm together with protruding osteophytes.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Shatin, Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessor and biostatistician will be blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Consultant and Clinical Assistant Professor (Honorary)
Study Record Dates
First Submitted
December 4, 2019
First Posted
January 6, 2020
Study Start
December 10, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
January 6, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share