The Use of Proximal Carpal Row Versus Iliac Crest Bone Graft in Total Wrist Fusion - a Randomized Controlled Multicenter Trial Comparing Two Operative Techniques (PROOF II - Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 主要终点
- Fusion rate (percent)
研究概览
简要总结
Study purpose is to compare the outcome after total wrist arthrodesis (TWA) with proximal carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone graft.
Patients with radiologically and clinically confirmed advanced osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting.
Baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the primary outcome is fusion rate.
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)
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
- •Age 18 - 75
- •Symptom duration > 3 months
- •American Society of Anaesthesiologists physical status (ASA) I-III
- •Fluent in written and spoken Finnish
排除标准
- •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)
- •Ulnar variance > 1 mm
- •Wrist pain treatable with partial wrist fusion
- •Previous partial wrist fusion
- •Alcohol or drug abuse
- •Neurological condition affecting upper limb function
- •Less than 6 months after another operation of the same upper limb
结局指标
主要结局
Fusion rate (percent)
时间窗: 6 months
次要结局
- Global improvement(6 months)
- Patient-Rated Wrist Evaluation (PRWE)(6 months)
- Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)(6 months)
- Operative time(Perioperative)
- Pain (Visual Analogue Scale)(6 months)
- Complications(12 months)
- Grip strength(6 months)
研究者
Samuli Aspinen
Principal investigator
Töölö Hospital