Clinical Trial to Monitor the Clinical Effectiveness of the DePuy ATN Trochanteric Nailing System in the Treatment of Trochanteric Fractures of the Proximal Femur
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Success in Terms of the Merle D'Aubigne Postel Score for Walk Category
研究概览
简要总结
The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system.
详细描述
Proximal femoral fractures are among the most common femoral fractures. In the past plates and screws were often used to repair these fractures but this treatment had limitations including restricted weight bearing. Intermedullary nailing is an alternative to plate and screw treatment. Weight bearing is allowed and the procedure can be a less invasive. Among intramedullary nailing complications are iatrogenic fractures that can be further divided into trochanteric and femoral shaft fractures. Trochanteric fractures often heal without additional intervention however femoral shaft fractures usually require an additional surgical procedure to facilitate healing. This study will monitor fracture healing using clinical and radiographic evaluations of subjects with trochanteric fractures of the proximal femur treated with the ATN system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willing to sign the approved consent form.
- •18 years of age
- •Skeletally mature
- •Have stable or unstable proximal femur fracture, including pertrochanteric, intertrochanteric, high subtrochanteric or any combination of the AO Proximal Femur Fracture Classification
排除标准
- •Subjects with concomitant lower extremity injuries or multiple trauma that would interfere with normal hip fracture rehabilitation.
- •Subjects who have isolated or combined medial femoral neck fractures.
- •Subjects who are unwilling or unable to comply with a rehabilitation program or are unwilling or unable to be assessed for 1 year following surgery.
- •Subjects who are pregnant or breastfeeding.
- •Subjects who are a prisoner or a known alcohol or drug abuser.
- •Subjects who have a prior surgical history in the affected hip, or conditions that may interfere with outcome or impede healing.
- •Subjects who have an obliterated medullary canal or other conditions that may complicate the reaming process.
- •Subjects who have evidence of active untreated infections that may spread to other areas of the body.
- •Subjects who have a highly communicable disease or pathology that may limit follow-up.
- •Subjects, who in the opinion of the Clinical Investigator, have an existing condition that indicates the Subject is not a good candidate for the study.
- •Subjects who are participating in another clinical investigation.
- •Subjects known to have allergies to titanium, aluminum, vanadium.
- •Subjects who are currently eligible for workman's compensation.
结局指标
主要结局
Success in Terms of the Merle D'Aubigne Postel Score for Walk Category
时间窗: 4 weeks, 3, 6 and 12 months
Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category
时间窗: 4 weeks, 3, 6 and 12 months
Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
Success in Terms of the Merle D'Aubigne Postel Score for Pain Category
时间窗: 4 weeks, 3, 6 and 12 months
Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
次要结局
- Six Item Screener and Ambulatory Status(4 weeks, 3, 6 and 12 months)
- Lower Extremity Measure (LEM)(4 weeks, 3, 6 and 12 months)
- Medical Imaging(4 weeks, 3, 6 and 12 months)
- SF-12(4 weeks, 3, 6 and 12 months)