An Outcome Study of Rheumatoid Hand Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 5
- 主要终点
- Michigan Hand Outcomes Questionnaire
研究概览
简要总结
A procedure called silicone metacarpophalangeal joint arthroplasty (SMPA) is sometimes used to treat knuckle deformity in the hands of rheumatoid arthritis (RA) patients. The purpose of this study is to compare the health outcomes of RA patients who choose to undergo SMPA surgery to RA patients who do not undergo surgery.
详细描述
The purpose of this study is to provide a better understanding of the effectiveness of SMPA, a procedure to correct knuckle deformity in the hands of rheumatoid arthritis patients. This study will examine whether rheumatoid arthritis patients who undergo SMPA will have better outcomes than those patients who do not have this surgery.
RA affects 2.1 million Americans and costs the United States an estimated $8.7 billion annually in medical costs and wages. RA is a progressive disease, and approximately 25% of RA patients experience hand deformities associated with the destruction of the metacarpophalangeal (MCP) joints. For the past 30 years, SMPA has been performed on such patients to correct metacarpophalangeal joint deformity in the rheumatoid hand. SMPA can provide pain relief, restoration of function, and aesthetic improvement to the patient. However, because data are limited on its efficacy, SMPA remains a controversial procedure. Hand surgeons and rheumatologists frequently disagree about the indications for this procedure and its value to their patients. In addition, most published studies have been hampered by inadequate consideration of research design, small sample size, and inconsistent outcome measures. The purpose of this study is to measure short- and long-term outcomes following SMPA. The study will also define indications of the surgery for specific patient groups and disease severity. The experiences of both surgery and rheumatology services will be used to jointly evaluate this surgical procedure.
This study is a multicenter, international outcomes study to evaluate RA patients with severe MCP joint problems. Patients will choose to be enrolled into a surgical group undergoing SMPA or a nonsurgical group. Patients will be evaluated at Month 6 and annually until the third year. Patient evaluations will be based on the Michigan Hand Outcomes Questionnaire, the Arthritis Impact Measurement Scales questionnaire, and standard, objective hand function tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of rheumatoid arthritis based on the diagnostic criteria of the American Rheumatology Association
- •Able to complete questionnaires in English
- •Sum of average metacarpophalangeal joint ulnar drift AND average metacarpophalangeal joint extensor lag of 50 degrees or greater
排除标准
- •Severe medical condition precluding surgery
- •Concomitant extensor tendon ruptures and metacarpophalangeal joint disease
- •Other joint injury of the hand (e.g., swan-neck deformity, boutonniere deformity) requiring surgery
- •Previous metacarpophalangeal joint replacement on their study hand
- •Disease modifying antirheumatic drugs (DMARDs) within the 3 months prior to study entry
结局指标
主要结局
Michigan Hand Outcomes Questionnaire
时间窗: Baseline, 6 months, 1 year, 2 years, 3 year
次要结局
- Standard, objective hand function tests(Baseline, 6 months, 1 year, 2 years, 3 years)
- Arthritis Impact Measurement Scales Questionnaire(Baseline, 6 months, 1 year, 2 years, 3 years)
研究者
Dr. Kevin C. Chung
Professor of Surgery
University of Michigan