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
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Short-Form Survey (SF-36)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor and biostatistician will be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arthroscopic Debridement
Patients who are randomized into this arm will receive arthroscopic debridement
干预措施: Arthroscopic Debridement (Procedure)
Arthroscopic Hemi-Trapeziectomy with Mini TightRope
Patients who are randomized into this arm will receive arthroscopic hemi-trapeziectomy with mini tightrope
干预措施: Arthroscopic Hemi-Trapeziectomy with Mini TightRope (Procedure)
结局指标
主要结局
Short-Form Survey (SF-36)
时间窗: Post-op 24 months
Generic health status instrument to assess quality of life
Disability of Arm, Shoulder and Hand (DASH) questionnaire
时间窗: Post-op 24 months
Specially designed tool to assess upper extremity disability and symptoms
Patients' Satisfaction Score
时间窗: Post-op 24 months
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Complications
时间窗: Post-operative up to 2 years
Any complications related to the surgery will be documented
Key and Tip Pinch
时间窗: Post-op 24 months
Will be measured in kg
Range of Motion (ROM)
时间窗: Post-op 24 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Kapandji Score
时间窗: Post-op 24 months
A tool for assessing the opposition of the thumb
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
时间窗: Post-op 24 months
VAS pain score at rest and exertion will be measured post-operatively
Grip Strength
时间窗: Post-op 24 months
Will be measured in kg
Short-Form Survey (SF-36)
时间窗: Post-op 6 months
Generic health status instrument to assess quality of life
Grip Strength
时间窗: Post-op 6 months
Will be measured in kg
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
时间窗: Pre-operative
Pre-operative VAS pain score at rest and exertion will be measured
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
时间窗: Post-op 3 months
VAS pain score at rest and exertion will be measured post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
时间窗: Post-op 6 months
VAS pain score at rest and exertion will be measured post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
时间窗: Post-op 12 months
VAS pain score at rest and exertion will be measured post-operatively
Short-Form Survey (SF-36)
时间窗: Pre-operative
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
时间窗: Post-op 3 months
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
时间窗: Post-op 12 months
Generic health status instrument to assess quality of life
Disability of Arm, Shoulder and Hand (DASH) questionnaire
时间窗: Pre-operative
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
时间窗: Post-op 3 months
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
时间窗: Post-op 6 months
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
时间窗: Post-op 12 months
Specially designed tool to assess upper extremity disability and symptoms
Grip Strength
时间窗: Post-op 12 months
Will be measured in kg
Patients' Satisfaction Score
时间窗: Pre-operative
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
时间窗: Post-op 3 months
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
时间窗: Post-op 6 months
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
时间窗: Post-op 12 months
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Grip Strength
时间窗: Pre-operative
Will be measured in kg
Grip Strength
时间窗: Post-op 3 months
Will be measured in kg
Key and Tip Pinch
时间窗: Pre-operative
Will be measured in kg
Key and Tip Pinch
时间窗: Post-op 3 months
Will be measured in kg
Key and Tip Pinch
时间窗: Post-op 6 months
Will be measured in kg
Key and Tip Pinch
时间窗: Post-op 12 months
Will be measured in kg
Range of Motion (ROM)
时间窗: Pre-operative
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
时间窗: Post-op 3 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
时间窗: Post-op 6 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
时间窗: Post-op 12 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Kapandji Score
时间窗: Pre-operative
A tool for assessing the opposition of the thumb
Kapandji Score
时间窗: Post-op 3 months
A tool for assessing the opposition of the thumb
Kapandji Score
时间窗: Post-op 6 months
A tool for assessing the opposition of the thumb
Kapandji Score
时间窗: Post-op 12 months
A tool for assessing the opposition of the thumb
次要结局
未报告次要终点
研究者
Michael Chu Kay MAK
Associate Consultant and Clinical Assistant Professor (Honorary)
Chinese University of Hong Kong