NCT01601301Unknown不适用
A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 11
- 主要终点
- Distraction Control: actual distraction rate vs. target distraction rate
研究概览
简要总结
The purpose of this study is to obtain post market performance and safety data of the Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.
详细描述
Subject data will be reviewed at the following visits:
- Preoperative
- Operative
- Every 7 to 14 days through Distraction Phase
- Every 4 to 6 weeks through Consolidation Phase
- 6-Month Post-Consolidation
- 12-Month Post-Consolidation
- 18-Month Post-Consolidation
- 24-Month Post-Consolidation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Leg length discrepancy ≥ 1.5 cm and ≤ 6.5 cm due to short femur or tibia
- •Weight ≤ 114 kg if implanted with the 10.7 mm or 12.5 mm diameter nail, or ≤ 57 kg if implanted with the 8.5 mm diameter nail
- •Skeletally mature
- •Intramedullary canal without offset
- •Tibia or femur sufficient to contain the implant
- •Availability, willingness, and sufficient cognitive awareness to comply with protocol procedures and schedule
- •Must sign informed consent to permit the use of personal health data
排除标准
- •Active infection or previous history of deep infection in the involved bone
- •Metal allergies or sensitivities to the components of the device
- •Distance from the nearest convenient external surface of the treated limb to the intramedullary canal > 38 mm for the 8.5 mm PRECICE nail, > 51 mm for the 10.7 mm PRECICE nail, or > 76 mm for the 12.5 mm PRECICE nail
- •Significant range of motion deficit of the adjacent joints
- •Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic or magnetic implant
- •Patients who require an MRI during implantation
- •Non-union
- •Impassable or obstructed intramedullary canal
- •Significant angular deformity that prevents device placement
- •Cannot bear weight on the contralateral limb
- •Procedural osteotomy cannot be made in an appropriate location
- •Deformities that require multilevel osteotomies or bi-lateral implantation at the time of study index surgery
- •Systemic bone disease
- •Pregnant or nursing women
- •Inadequate vascularity or evidence of vascular disease or peripheral neuropathy
- •Malignancies or tumors in the involved bone
- •Patient is a drug abuser
- •Open wounds or ulcers that could compromise treatment
研究组 & 干预措施
PRECICE System
Experimental
干预措施: PRECICE System (Device)
结局指标
主要结局
Distraction Control: actual distraction rate vs. target distraction rate
时间窗: Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days
次要结局
- Number of days to complete lengthening(Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days)
- Adverse Events(Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months)
- Procedure-related complications(Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months)
- Number of days to complete full weight bearing(Up to an expected average of 99 days.)
- Number of days to full consolidation(Following completion of the subject's distraction regimen, every 4-6 weeks until the subject's treated limb is evaluated as consolidated, an expected average of 66 days)
- Bone Union(Following completion of the subject's distraction regimen, every 4-6 weeks until the subject's treated limb is evaluated as consolidated, an expected average of 66 days)
- Pain(Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months)
- Healing Index(Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months)
- Device-related complications(Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months)
研究者
研究点 (11)
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