A Double-blinded Randomized Controlled Multicenter Trial Comparing Proximal ROw carpectOmy and Four-corner Fusion (PROOF) for Osteoarthritis of the Wrist
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 5
- 主要终点
- Patient-Rated Wrist Evaluation
研究概览
简要总结
Study purpose is to compare the outcome after proximal row carpectomy (PRC) vs four-corner fusion (FCA) for SLAC/SNAC II-III type osteoarthritis (OA) in a double-blinded randomized controlled study setting.
Patients with radiologically and clinically confirmed OA are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either PRC or FCA. The study will be patient and assessor blinded.
Baseline data is collected preoperatively and is followed by a follow-up visits at 2 and 6 weeks, 3, 6, 12 months, and 5, 10 years after the intervention. Unveiling of the allocation is at 12 months post-intervention.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SLAC/SNAC II-III
- •Age 18 - 75
- •Symptom duration > 3 months
- •American Society of Anaesthesiologists physical status (ASA) I-II
排除标准
- •Patient eligible for SL reconstruction or scaphoid
- •Ulnocarpal/pancarpal arthritis
- •Lunate fossa, proximal lunate arthrosis or both
- •Age <18 or >75 years
- •Rheumatoid arthritis
- •Heavy smoking (> 20 cigarettes per day)
- •Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids)
- •Alcohol or drug abuse
- •Neurological condition affecting upper limb function
结局指标
主要结局
Patient-Rated Wrist Evaluation
时间窗: 12 months
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
次要结局
- Quick-Disabilities of the Arm, Shoulder and Hand(12 months)
- Pain (Visual Analogue Scale)(12 months)
- Patient-rated Quality of Life (EQ-5D)(12 months)
- Global improvement(12 months)
- Grip strength(12 months)
- Wrist range of motion (ROM)(12 months)
- Cost-effectiveness(12 months)
- Complications(12 months)
研究者
Samuli Aspinen
Principal investigator
Töölö Hospital