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临床试验/NCT01376024
NCT01376024招募中不适用

Prospective Study on Basal Joint Arthritis of the Thumb

Columbia University6 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2007年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
6
主要终点
Flexion/extension range of MCP joint

研究概览

简要总结

The data in this prospective registry will be used 1) to define which surgical and nonoperative techniques are most effective at providing pain relief, restoring function, are cost effective, and patients are satisfied with their outcomes; and 2) to design focused clinical questions regarding the optimal treatment of basal joint arthritis of the thumb in future randomized controlled trials. There are no interventions or changes in patient care associated with this study.

详细描述

Basal joint arthritis of the thumb is a common condition associated with considerable morbidity. Many non-operative and operative treatments have been described but few multi-center prospective evidence based trials comparing standard treatments have been done. This continuing search for consensus of best clinical practices has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Through the systematic collection of data regarding patient-specific characteristics, treatment interventions, and longitudinal functional outcome measurements the investigators believe patient outcomes and satisfaction can improve through the elucidation of risk factors for disease progression, and the timing and selection of treatment modalities, either conservative or surgical, for any particular patient. The establishment of a multi-center clinical registry will greatly facilitate these goals.

The study hypothesizes that there exist effective non-operative and operative treatments for certain patient populations with basal joint arthritis of the thumb. There also exists a functionally superior, cost effective, and low risk non-operative or minimally invasive operative treatment regime to alleviate pain and slow the progression of disease in those with less advanced disease. Likewise, there is significant functional, health utility, and economic advantage to surgically treating advanced basal joint arthritis with one of the popularized procedures currently in practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 who have symptomatic basal joint arthritis.
  • Patients who are capable of providing informed consent.

排除标准

  • Patients younger than 18 years old at the time of enrollment.
  • Patients with neuromuscular disease affecting the operated hand, not caused by the CMC operation.
  • Patients with known inflammatory arthritic conditions, such as rheumatoid or psoriatic arthritis.
  • Patients with a history of or current infection of the basal joint of the affected hand.
  • Patients who are demented or are unable to provide informed consent.
  • Patients unable to comply with study guidelines.
  • Patients who have metacarpophalangeal joint hyperextension are NOT excluded. These patients will be followed and if they receive a capsulodesis or other procedure at the MCPJ at the same time as their basal joint arthroplasty this will be noted in their data records.

结局指标

主要结局

Flexion/extension range of MCP joint

时间窗: Baseline, 6 weeks, 3 months, 6 months, 1 year

Range of motion measured in degrees of the metacarpophalangeal (MCP) joint.

Flexion/extension range of IP joint

时间窗: Baseline, 6 weeks, 3 months, 6 months, 1 year

Range of motion measured in degrees of the interphalangeal (IP) joint.

Grip strength

时间窗: Baseline, 6 weeks, 3 months, 6 months, 1 year

This will be quantified with use of a Jamar dynamometer set in the second position.

Key-pinch strength

时间窗: Baseline, 6 weeks, 3 months, 6 months, 1 year

A 30-lb pinch dynamometer will used to determine lateral key-pinch strength.

Tip-pinch strength

时间窗: Baseline, 6 weeks, 3 months, 6 months, 1 year

A 30-lb pinch dynamometer will used to determine lateral tip-pinch strength.

次要结局

  • Disability of Arm, Shoulder and Hand (DASH) score(Baseline, 6 weeks, 3 months, 6 months, 1 year)
  • SF-36 questionnaire score(Baseline, 6 weeks, 3 months, 6 months, 1 year)
  • Average total costs per patient(Up to 1 year)
  • Prevalence of arthritis progression(Baseline, 6 weeks, 3 months, 6 months, 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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