Comparison of Trapeziectomy With Suspensionplasty and Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis: Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand)
研究概览
简要总结
This study compares and evaluates differences in movement analysis, patient-reported outcome, radiological assesment and muscular function between patients undergoing carpometacarpal joint arthroplasty with use of modern implants and trapeziectomy with suspensionplasty
详细描述
Osteoarthritis of first carpometacarpal joint is the most common degenerative disease of upper limb. According to data available in literature, it affects about 30% of women and 6% of men at the age of 45. Increasing with age, it rises up to 90% in people by the age of 80. Due to more widely spread electronic devices in offices, at work, at home which requires usage of thumb, increase in numbers mentioned above is strongly probable. The main symptoms are: pain, loose of grip strength and loose of function. The latter is most important fact, since about 50% of hand function is possible only with healthy thumb.
In many cases osteoarthritis can be treated by combined NSAIDs and splinting with rehabilitation. Sometimes when symptoms do not respond to non-operative treatment, there is a need for surgery. Trapeziectomy is the most common choice for operative treatment for end-stage basal thumb osteoarthritis. However, many other techniques were developed, there is continuous dispute over selecting the optimal . One of the most promising is arthroplasty using prosthesis. Last years many important advances were made in a design of implant and materials. Moreover the investigators now have many longer outcomes of such operation made in the past. All this data make us think more about using this technique often, since there are papers which show superiority over classical trapeziectomy. Even though there are several studies comparing functional and objective outcome of those techniques, there is a lack of evidence in terms of biomechanical analysis, thenar muscle activity and changes in movement patterns. Moreover there is no study published so far which considers modern implants and trapeziectomy with suspensionplasty. The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) and X-ray measurement, electromyography both pre- and post-operatively.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor will not be informed which type of prosthesis was used in particular patient.
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
- •osteoarthritis of carpometacarpal joint III or III/IV in Eaton classification assessed by two different radiologists
- •symptoms that do not respond to non-operative treatment for 8 weeks
- •no counterindications for anaesthesia
- •signed agreement for taking a part into trial
排除标准
- •patient do not agree to take a part into study
- •problems with communication with patient
- •unstable cardiac disease
- •reoperations
- •previous surgical interventions in hand
- •neuro-muscular diseases
- •rheumatological background of disease
- •diagnosed cervical spine disorders
结局指标
主要结局
Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand)
时间窗: at baseline, 6 weeks and 6 months postoperatively
To measure overall disabilities of upper limb. Results range from 0 to 100, with lower scores corresponding to better outcomes.
次要结局
- Changes in patients reported outcomes - SF-36 (Short Form 36)(at baseline, 6 weeks and 6 months postoperatively)
- Changes in carpometacarpal, carpophalangeal and wrist range of motion(at baseline, 6 weeks and 6 months postoperatively)
- Changes in patients reported outcomes - PRWE (Patient Related Wrist Evaluation)(at baseline, 6 weeks and 6 months postoperatively)
- Changes in patients reported outcome measures - VAS (Visual Analogue Score)(at baseline, 6 weeks and 6 months postoperatively)
- Arthroplasty revision surgeries(at baseline, 6 weeks and 6 months postoperatively)
- Changes in usage of painkillers(at baseline, 6 weeks and 6 months postoperatively)
- Operation related complications(at baseline, 6 weeks and 6 months postoperatively)
- Biomechanical 3D motion analysis(at baseline, 6 weeks and 6 months postoperatively)
- Radiological outcome on x-rays(at baseline, 6 weeks and 6 months postoperatively)
- Muscle strength outcomes(at baseline, 6 weeks and 6 months postoperatively)
- Changes in patients reported outcomes - Michigan Hand Outcomes Questionaire(at baseline, 6 weeks and 6 months postoperatively)
- EMG measured bioelectrical potentials(at baseline, 6 weeks and 6 months postoperatively)
