Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Stability of Acetabular and femoral components
研究概览
简要总结
The specific aim is to quantify the stability of the acetabular and femoral components of a revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In this way, the investigators will gain insight into the outcome of the current state of the art of revision arthroplasty surgery. In the past, acetabular and femoral component stability has been measured using radiostereometric analysis (RSA) and when patients having revision total hip operations were compared to patients undergoing primary total hip operations it was possible to determine differences in stability and this was predictive of the intermediate to long-term performance of the acetabular and femoral reconstruction. The investigators propose to use this established, high resolution technique to assess and compare the stability of the revision implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female.
- •25 to 75 years of age.
- •Subjects requiring revision total hip replacement.
- •Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.
排除标准
- •Subjects with limited life span.
- •Subjects with difficulty in comprehending study protocol for any reason.
- •Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, or any other major medical complication which could substantially reduce longevity, put them at further risk due to immunocompromisation or increase the risk of infection.
- •Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.
- •A urine HCG will be done in all women of child bearing potential prior to RSA imaging at each follow-up visit. The result will be recorded in the research record.
研究组 & 干预措施
Revision Total Hip
patients recieving a revision total hip replacement will be assessed for implant stability and wear using RSA. Tantalum beads will be placed in the polyethylene and surrounding pelvic and femoral bone.
干预措施: Bead placement during revision hip replacement surgery (Procedure)
结局指标
主要结局
Stability of Acetabular and femoral components
时间窗: 1, 2, 3, 5 years after surgery
RSA films will be taken at the prescribed time intervals to measure component mothion over time.
次要结局
- Wear of the polyethlene component(1, 2, 3, 5 years after surgery)
研究者
Charles R. Bragdon
Reseach scientist
Massachusetts General Hospital