A Multi-center, Investigator-blinded, Randomized, Parallel Group, Superiority Study to Compare the Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Patient reported wrist and hand evaluation (PRWHE)
研究概览
简要总结
A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.
详细描述
A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb (CMC1). The primary outcome is Patient Reported Wrist and Hand Evaluation (PRWHE) at 6 months after the randomization to treatment group. Secondary measures include PRWHE at 3 months, 1 year, 2 years and 5 years, grip strength, and global assessment of change.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living
- •Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (NSAIDs or paracetamol, implemented for at least three months.
- •Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain)
- •Age > 45 years
- •ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System)
- •Ability to speak, understand and read in the language of the clinical site
- •Provision of informed consent from the participant
排除标准
- •Patients' main complaint is due to some other problem than primary thumb basal joint (CMC1) osteoarthritis or patient will undergo any other surgery in conjunction with trapeziectomy
- •Neurologic condition affecting the function or symptoms of the upper extremity
- •<6 months from other surgical procedure of the upper extremities
- •Rheumatoid arthritis or other inflammatory joint disease
- •Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides
- •Previous operation due tothumb basal joint (CMC1) osteoarthritis for either side
- •>45 degrees of hyperextension in the thumb MP joint in resting position (zig zag deformity)
- •Patient is unable to continue his/her current job due to thumb pain
结局指标
主要结局
Patient reported wrist and hand evaluation (PRWHE)
时间窗: 6 months
PROM questionnaire
次要结局
- Grip and pinch strength(6 months)
- Patient reported wrist and hand evaluation (PRWHE)(3 months, and 1, 2, 5 years)
- Patient accepted symptom state(3 and 6 months, and 1, 2, and 5 years)
- EUROQOL EQ-5D-5L(3 and 6 months, and 1, 2, and 5 years)
- Global improvement(3 and 6 months, and 1, 2, and 5 years)
研究者
Jarkko Jokihaara
Associate professor
Tampere University Hospital