Osteoarthritis Thumb Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analogue Scale (VAS) Pain Score at Rest and Exertion | Pre-operative VAS pain score at rest and exertion will be measured | Pre-operative | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Short-Form Survey (SF-36) | Generic health status instrument to assess quality of life | Pre-operative | |
Primary | Short-Form Survey (SF-36) | Generic health status instrument to assess quality of life | Post-op 3 months | |
Primary | Short-Form Survey (SF-36) | Generic health status instrument to assess quality of life | Post-op 6 months | |
Primary | Short-Form Survey (SF-36) | Generic health status instrument to assess quality of life | Post-op 12 months | |
Primary | Short-Form Survey (SF-36) | Generic health status instrument to assess quality of life | Post-op 24 months | |
Primary | Disability of Arm, Shoulder and Hand (DASH) questionnaire | Specially designed tool to assess upper extremity disability and symptoms | Pre-operative | |
Primary | Disability of Arm, Shoulder and Hand (DASH) questionnaire | Specially designed tool to assess upper extremity disability and symptoms | Post-op 3 months | |
Primary | Disability of Arm, Shoulder and Hand (DASH) questionnaire | Specially designed tool to assess upper extremity disability and symptoms | Post-op 6 months | |
Primary | Disability of Arm, Shoulder and Hand (DASH) questionnaire | Specially designed tool to assess upper extremity disability and symptoms | Post-op 12 months | |
Primary | Disability of Arm, Shoulder and Hand (DASH) questionnaire | Specially designed tool to assess upper extremity disability and symptoms | Post-op 24 months | |
Primary | Patients' Satisfaction Score | To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied) | Pre-operative | |
Primary | Patients' Satisfaction Score | To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied) | Post-op 3 months | |
Primary | Patients' Satisfaction Score | To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied) | Post-op 6 months | |
Primary | Patients' Satisfaction Score | To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied) | Post-op 12 months | |
Primary | Patients' Satisfaction Score | To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied) | Post-op 24 months | |
Primary | Grip Strength | Will be measured in kg | Pre-operative | |
Primary | Grip Strength | Will be measured in kg | Post-op 3 months | |
Primary | Grip Strength | Will be measured in kg | Post-op 6 months | |
Primary | Grip Strength | Will be measured in kg | Post-op 12 months | |
Primary | Grip Strength | Will be measured in kg | Post-op 24 months | |
Primary | Key and Tip Pinch | Will be measured in kg | Pre-operative | |
Primary | Key and Tip Pinch | Will be measured in kg | Post-op 3 months | |
Primary | Key and Tip Pinch | Will be measured in kg | Post-op 6 months | |
Primary | Key and Tip Pinch | Will be measured in kg | Post-op 12 months | |
Primary | Key and Tip Pinch | Will be measured in kg | Post-op 24 months | |
Primary | Range of Motion (ROM) | ROM of interphalangeal joint and metacarpal joint of thumb will be measured | Pre-operative | |
Primary | Range of Motion (ROM) | ROM of interphalangeal joint and metacarpal joint of thumb will be measured | Post-op 3 months | |
Primary | Range of Motion (ROM) | ROM of interphalangeal joint and metacarpal joint of thumb will be measured | Post-op 6 months | |
Primary | Range of Motion (ROM) | ROM of interphalangeal joint and metacarpal joint of thumb will be measured | Post-op 12 months | |
Primary | Range of Motion (ROM) | ROM of interphalangeal joint and metacarpal joint of thumb will be measured | Post-op 24 months | |
Primary | Kapandji Score | A tool for assessing the opposition of the thumb | Pre-operative | |
Primary | Kapandji Score | A tool for assessing the opposition of the thumb | Post-op 3 months | |
Primary | Kapandji Score | A tool for assessing the opposition of the thumb | Post-op 6 months | |
Primary | Kapandji Score | A tool for assessing the opposition of the thumb | Post-op 12 months | |
Primary | Kapandji Score | A tool for assessing the opposition of the thumb | Post-op 24 months | |
Primary | Complications | Any complications related to the surgery will be documented | Post-operative up to 2 years |
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