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临床试验/NCT03031964
NCT03031964终止不适用

Survivorship, Clinical and Functional Outcomes of the Multihole Revision Acetabular Cup

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年12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
1
主要终点
survivorship of a multihole revision acetabular cup

研究概览

简要总结

This study will evaluate patients receiving a multihole revision acetabular implant for total hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of the implanted prosthesis.

详细描述

Data will be collected preoperatively, and at the standard of care (SOC) office visits at 4 weeks, 1 year, 2 years, 5 years and 10 years postoperatively. The research coordinator at each site will identify, recruit, and prospectively follow the 60 patients at his/her site. Patient demographics (e.g., age, gender, body mass index (BMI)), comorbidities, reason for revision, Paprosky classification, native femoral head measurement (mm) etc. will be collected preoperatively. The study coordinator will contact patients prior to each visit to ensure patient compliance. At each visit, A-P and cross-lateral radiographic evaluation (i.e., use of Engh classification to quantify osteolysis/loosening) will occur. In addition, patients will be assessed for any complications (e.g., dislocation, emergency department visits, infection, reoperation, etc.). Patients will complete the Hip disability and Osteoarthritis Outcome Score (HOOS) and Veterans Rand 12 (VR-12) forms (including a specific question regarding groin pain) and a pain assessment. In the event that a patient has relocated and/or refuses to return to the office for the 5-year visit, a script will be sent to the patient to have x-rays done and sent to the PI, and questionnaires will be mailed. All data will be entered and maintained in RedCap.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients requiring revision total hip replacement of the acetabular component or complicated primary total hip replacement.
  • Femoral stem (either retained or replaced) is a compatible Stryker stem.
  • Patient is willing to comply with follow-up requirements (e.g. will return for long-term follow-up visits)
  • Age: 18-85 years

排除标准

  • Patient has a BMI > 40
  • Exclude revision for infection
  • Patient is undergoing bilateral THA surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery
  • Patient has history of radiation therapy
  • Patient has known diagnosis of renal disease
  • Patient has known diagnosis of osteoporosis

结局指标

主要结局

survivorship of a multihole revision acetabular cup

时间窗: 10 years

evaluate standard of care radiographs for any signs of implant compromise such as loosening or osteolysis

次要结局

  • functional outcomes of multihole revision acetabular cup(10 years)
  • assess pain levels in patients who receive multihole revision acetabular cup(10 years)
  • Clinical outcomes of multihole revision acetabular cup(10 years)

研究者

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

Carlos Higuera-Rueda

Staff Surgeon

The Cleveland Clinic

研究点 (1)

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