Trapeziectomy With Ligament Reconstruction and Tendon Interposition or Simple Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- Isala
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Michigan Hand Outcomes Questionnaire (MHOQ)
研究概览
简要总结
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. These studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage 4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases the chance for collapse of the first metacarpal bone and associated problems.
The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •40 years of age or more
- •Symptomatic trapeziometacarpal osteoarthritis
- •Eaton & Glickel stage 4
排除标准
- •An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
- •Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
- •Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
- •Symptomatic carpal tunnel syndrome in same hand.
- •Symptomatic Quervain's tenosynovitis in same hand.
- •Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
- •Insufficient knowledge of Dutch language.
结局指标
主要结局
Michigan Hand Outcomes Questionnaire (MHOQ)
时间窗: 1 year after surgery
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
次要结局
- Michigan Hand Outcomes Questionnaire (MHOQ)(1 and 5 years after surgery)
- Disabilities of Arm Shoulder and Hand (DASH)(1 and 5 years after surgery)
- Grip strength(1 and 5 years after surgery)
- Thumb mobility(1 and 5 years after surgery)
- Complications(1 and 5 years after surgery)
- Return to work(1 and 5 years after surgery)