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临床试验/NCT02006251
NCT02006251终止不适用

Comparison of Acetabular Shell Position Using Real-Time Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
2
主要终点
Difference Between Planned and Actual Values of Abduction

研究概览

简要总结

The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty.

The investigators will enroll 44 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of real-time instrument from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments.

The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.

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)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:
  • Primary, unilateral anterior or posterior total hip arthroplasty
  • 18 to 85 years old at time of surgery
  • Able to get a pre- and post-operative CT scan at the Cleveland Clinic

排除标准

  • Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.
  • Pregnancy
  • Incarceration
  • Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.

结局指标

主要结局

Difference Between Planned and Actual Values of Abduction

时间窗: Through 2 weeks after surgery.

The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.

次要结局

  • Difference Between Planned and Actual Values of Version(Through 2 weeks after surgery)
  • Difference in the Time for Acetabular Preparation and Shell Placement Between the Two Groups(Intraoperatively (during surgery))

研究者

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

Wael Barsoum

Vice-chairman, Department of Orthopaedic Surgery

The Cleveland Clinic

研究点 (2)

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