Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary Total Hip Arthroplasty Using Radiostereometric Analysis (RSA)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Short-term femoral head penetration,long-term steady state wear of polyethylene. Stability of acetabular & femoral components. Clinical questionnaires to assess preop,clinical outcomes,& patient satisfaction.
研究概览
简要总结
The specific aim of this proposed study is to conduct a prospective RSA clinical study at Massachusetts General Hospital involving 50 patients receiving primary total hip replacements. All patients will receive the vitamin E treated polyethylene acetabular inserts. Short-term femoral head penetration and long-term steady state wear of the polyethylene will be measured using both RSA and Martell analysis techniques. Stability of the acetabular and femoral components will be measured in all patients using RSA analysis. The stability of the cemented femoral stems will be compared to the stability of the cementless femoral components as well as to historic data in the literature. In addition, all patients will complete a self-administered questionnaire to assess the clinical outcome of the surgery and patient satisfaction.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •20 to 75 years of age
- •Subjects requiring primary total hip replacement
- •Subjects with diagnosis of osteoarthritis, avascular necrosis, or traumatic arthritis
- •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 inflammatory disease, previous infection or those requiring revision hip surgery.
- •Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used.
- •Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia
- •Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity.
- •Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.
结局指标
主要结局
Short-term femoral head penetration,long-term steady state wear of polyethylene. Stability of acetabular & femoral components. Clinical questionnaires to assess preop,clinical outcomes,& patient satisfaction.
时间窗: 5 years
次要结局
未报告次要终点
研究者
Henrik Malchau
Director of Research
Massachusetts General Hospital