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临床试验/NCT04528459
NCT04528459终止不适用

Computer-Assisted Surgery for Internal Fixation of Peritrochanteric Femur Fractures: A Randomized Controlled Study

Columbia University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Traditional fluoroscopy

Active Comparator

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wakenda K. Tyler, MD, MPH

Associate Professor of Orthopedic Surgery

Columbia University

研究点 (2)

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