A 4-Anchor Construct With Internal Bracing Technique for Surgical Treatment of Perilunate Dislocations: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical Functional Assessment
研究概览
简要总结
The purpose of the research study is to determine the overall clinical and radiographic outcome differences between internal brace technique and the gold standard Kirschner wires (K-wire) technique for treatment of perilunate dislocations (e.g. nonunion, reoperation, infection, fixation failure, etc.). A secondary purpose is to determine the specific types of complications and their incidence rates with respect to internal brace technique and the gold standard Kirschner wires (K-wire) technique (e.g. range of motion losses, pain, numbness, weakness, etc).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature patients who have undergone surgical fixation of perilunate dislocation
排除标准
- •Perilunate dislocations with concomitant carpal fracture(s)
- •Pediatric patients (Age < 18 years-old)
- •Patients whose age is greater than or equal to 89 years
- •History of previous perilunate dislocation on ipsilateral side
结局指标
主要结局
Clinical Functional Assessment
时间窗: From enrollment to 2-years postoperative
assessment to measure wrist flexion/extension (degrees), wrist flexion/extension arc (degrees), and composite wrist function
Quick DASH Form
时间窗: From enrollment to 2-years postoperative
Assessment of symptoms and ability to perform certain activities.
次要结局
- Specific types of complications and their incidence rates(From enrollment to 2-years postoperative)
研究者
Bryan D Brown,MD
Orthopedic Hand, Elbow & Shoulder Surgeon
Orlando Health, Inc.