Prospective, Randomized, Double-Blinded, Controlled Multi-Center Clinical Trial Evaluating the Use of Non-Invasive CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
试验速览
- 阶段
- 不适用
- 入组人数
- 217
- 试验地点
- 9
- 主要终点
- Change overtime of Olerud and Molander Ankle Score (OMAS)
研究概览
简要总结
The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization. The initiation of the adjunctive treatment is to begin within 11 days of surgical stabilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is diagnosed with an unstable, closed, isolated fracture of the ankle and underwent operative stabilization with plate(s) and/or screws (Weber Ankle Fracture Classification B and C)
排除标准
- •Subject has an open fracture
- •Subject has any additional fractures of another bone besides the ankle fracture that is to be treated in the study including the contralateral ankle
- •Surgical stabilization was definitively performed with an external fixation system
- •Surgical stabilization was performed in such a manner that it will result in a fusion of the ankle joint
- •Malreduced Ankle as described by Phillips, et al 1985 JBJS
- •Surgical procedure included the use of osteoinductive materials in addition to rigid fixation
- •BMI ≥ 40 kg/m2
研究组 & 干预措施
Investigational Group
Standard Rigid Fixation + Active OL1000 device
干预措施: Active Combined Magnetic Field OL1000 Bone Growth Stimulator (Device)
Control Group
Standard Rigid Fixation + Sham OL1000 device
干预措施: Sham Combined Magnetic Field OL1000 Bone Growth Stimulator (Device)
结局指标
主要结局
Change overtime of Olerud and Molander Ankle Score (OMAS)
时间窗: 6 weeks, 8 weeks, 10 weeks and 12 weeks
Non-powered, composite safety endpoint consisting of: Joint Position Outcome Radiographic Failure and Repeat, Unplanned Surgery at the Operative Site and Device-Related Serious Adverse Events
时间窗: 6 months & 12 months
次要结局
未报告次要终点