Measuring the Quality of Life in Patients Receiving a Partial Trapeziectomy (PT) Using a "Minimalist Approach" Versus a Complete Trapeziectomy With Ligament Reconstruction and Tendon Interposition (T+LRTI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Change in Health Related Quality of Life (HRQOL) as measured by the Short Form 36v2 (SF-36)
研究概览
简要总结
The purpose of this study was to measure the differences in Health Related Quality of Life (HRQOL) and functional measurements between two groups of patients with Carpometacarpal Osteoarthritis of the thumb.
详细描述
Two patient groups, who have been diagnosed with Carpometacarpal Osteoarthritis of the thumb were compared to measure the Health Related Quality of life (HRQOL) and functional outcomes following two different surgical procedures. The first procedure is currently the most used procedure is North America, Trapeziectomy with Ligament Reconstruction and Tendon Interposition (T+LRTI); this procedure is compared to Partial Trapeziectomy and Tendon Interposition (PT+TI). HRQOL is measured using three questionnaires: one generic, one condition specific and one to measure utility (costs). Patients received their procedures from the respective surgeons and then came in for regular follow up at 1, 3, 6 and 12 months. At these follow up visits the questionnaires and functional measurements (including grip, key pinch and tip pinch strength), were completed
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Diagnosis of advanced stage (Eaton stages II-IV) Carpometacarpal joint (CMCJ) osteoarthritis (OA of the thumb
- •Willingness to undergo surgery for CMCJ OA;
- •Over the age of 18;
- •Able to provide informed consent; and
- •Ability to read and comprehend English to complete the HRQOL questionnaires
排除标准
- •Diagnosis of Eaton stage I CMCJ OA of the thumb [17]; 2) Under the age of 18; 3) Presence of any concomitant hand pathology (including rheumatoid arthritis, neuropathy and traumatic arthritis); and 4) Previous surgery on the same hand or currently under consideration for other unrelated hand surgery
结局指标
主要结局
Change in Health Related Quality of Life (HRQOL) as measured by the Short Form 36v2 (SF-36)
时间窗: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively
The Short-Form 36v2 \[SF-36\] is a Generic HRQOL questionnaire
Change in Health Related Quality of Life (HRQOL) as measured by the Disabilities of the Arm, Shoulder and Hand (DASH)
时间窗: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively
The DASH is a condition specific questionnaire
Change in HRQOL as measured by The EuroQol-5D-3L [EQ-5D]
时间窗: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively
The EQ-5D is a questionnaire that allows utility to be calculated
次要结局
- Change in functional performance as measured by Key Pinch Strength(1 week pre-operatively and 3, 6 and 12 month post-operatively)
- Change in functional performance as measured by Grip Strength(1 week pre-operatively and 3, 6 and 12 month post-operatively)
- Change in functional performance as measured by Two-Point Pinch Strength(1 week pre-operatively and 1, 3, 6 and 12 month post-operatively)