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临床试验/NCT04217928
NCT04217928Unknown不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年12月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Chu Kay MAK

Associate Consultant and Clinical Assistant Professor (Honorary)

Chinese University of Hong Kong

研究点 (1)

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