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
- Kapandji Score
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
结局指标
主要结局
Kapandji Score
时间窗: Post-op 24 months
A tool for assessing the opposition of the thumb
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
Complications
时间窗: Post-operative up to 2 years
Any complications related to the surgery will be documented
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
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
Short-Form Survey (SF-36)
时间窗: Post-op 24 months
Generic health status instrument to assess quality of life
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)
Grip Strength
时间窗: Post-op 24 months
Will be measured in kg
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
