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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis Thumb

Intervention / Treatment
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* Procedure: Arthroscopic Debridement
* Procedure: Arthroscopic Hemi-Trapeziectomy with Mini TightRope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthroscopic Debridement<br>Patients who are randomized into this arm will receive arthroscopic debridement | Procedure: Arthroscopic Debridement<br>* Arthroscopic debridement will be performed under portal site local anaesthesia.<br>|
| Active Comparator: Arthroscopic Hemi-Trapeziectomy with Mini TightRope<br>Patients who are randomized into this arm will receive arthroscopic hemi-trapeziectomy with mini tightrope | Procedure: Arthroscopic Hemi-Trapeziectomy with Mini TightRope<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |