NCT04210687进行中（未招募）不适用
A Randomized Comparison Between Trapeziectomy and Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in pain on load NRS (numerical rating scale)
研究概览
简要总结
A randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.
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
- Double (Participant, Outcomes Assessor)
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
- •Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test).
- •Pain at rest.
- •Conservative treatment >6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection)
排除标准
- •Rheumatoid arthritis.
- •Ongoing infection in the hand or wrist. -
- •History of gout or pseudo gout.
- •Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- •Intra-articular injection in the affected joint within 6 months.
- •Eaton Littler class 4 (STT joint involved).
研究组 & 干预措施
Trapeziectomy
Active Comparator
Standard simple trapeziectomy, no pins.
干预措施: Trapeziectomy (Procedure)
trapeziometacarpal limited excision
Active Comparator
Trapeziometacarpal limited excision; Narrow pseudarthrosis of the trapeziometacarpal joint.
干预措施: trapeziometacarpal limited excision (Procedure)
结局指标
主要结局
Change in pain on load NRS (numerical rating scale)
时间窗: Preoperatively, 1, 3 and 5 years postoperatively
Change in rated pain on load from preoperatively to 1, 3 and 5 years postoperatively
次要结局
- Change in thumb strength(Preoperatively, 1, 3 and 5 years postoperatively)
- Change in DASH - Disability of the Arm, Shoulder and Hand(Preoperatively, 1, 3 and 5 years postoperatively)
- Change in HADS - Change hospital Anxiety and Depression score(Preoperatively, 1, 3 and 5 years postoperatively)
- Change in PCS - Pain Catastrophizing Score(Preoperatively, 1, 3 and 5 years postoperatively)
- Change in Thumb base motion(Preoperatively, 1, 3 and 5 years postoperatively)
- Change in Nelson Thumb score(Preoperatively, 1, 3 and 5 years postoperatively)
- Change in EQ-5D(1, 3 and 5 years postoperatively)
- Change in PRWHE - Patient-Rated Wrist and Hand Evaluation(Preoperatively, 1, 3 and 5 years postoperatively)
研究者
Maria Wilcke
Prinicipal investigator
Karolinska Institutet
研究点 (1)
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