Computer-Assisted Surgery for Internal Fixation of Peritrochanteric Femur Fractures: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Tip-apex Distance (TAD)
研究概览
简要总结
The purpose of this study is to assess whether the Stryker© ADAPT™ augmented-reality platform can assist surgeons in optimizing placement of the lag screw component of the Stryker© Gamma™ cephalomedullary nail.
详细描述
This will be a prospective, randomized, single-blinded, controlled trial with two treatment cohorts. Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw. Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw. Patients will be blinded to treatment group allocation as will clinicians/researchers during data processing and analysis.
The primary outcome will be tip-apex distance, as measured on anteroposterior and lateral hip radiographs. Secondary outcomes will be position of the lag screw as described by Cleveland et al, operative time, fluoroscopy time, and number of Kirschner wire passes prior to final placement of the lag screw. Additionally, evidence of lag screw cutout on hip radiographs, hip range of motion relative to the contralateral hip, overall mobility, social dependency, and pain level will be assessed at 3 month, 6 month, 1 year, and 2 year follow up visits.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be blinded to treatment group allocation, as will outcomes assessors. Clinicians performing the procedures will not be blinded.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Traditional fluoroscopy
Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).
干预措施: Traditional fluoroscopy (Radiation)
Stryker© ADAPT™ platform
Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™platform to assist with insertion of the lag screw.
干预措施: Stryker© ADAPT™ platform (Device)
结局指标
主要结局
Tip-apex Distance (TAD)
时间窗: Immediate post-operative period
Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays
次要结局
- Lag Screw Position(Immediate postoperative period)
- Operative Time(Intraoperative period)
- Fluoroscopy Time(Intraoperative period)
- K-wire Passes(Intraoperative period)
- Evidence of Lag Screw Cut-out(3 months, 6 months, 1 year, and 2 years after surgery)
- Hip Range of Motion(3 months, 6 months, 1 year, and 2 years after surgery)
- Patient Mobility and Social Dependency(3 months, 6 months, 1 year, and 2 years after surgery)
- Pain Level(3 months, 6 months, 1 year, and 2 years after surgery)
研究者
Wakenda K. Tyler, MD, MPH
Associate Professor of Orthopedic Surgery
Columbia University
