Long-Term Multi-center Evaluation of E-Poly and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Survivorship: length of time implant remains without revision
研究概览
简要总结
There are two distinct aims of this study:
- This prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty subjects. The clinical outcome of E-Poly will be compared to a group of subjects receiving Arcom XL polyethylene.
- This study is also designed to document the long-term (10-year) radiographic and clinical outcomes of a new cementless acetabular component having a titanium porous surface (Regenerex). The clinical outcome of this new FDA cleared device will be compared a group of subjects receiving an acetabular component having a plasma sprayed surface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects requiring primary total hip replacement
- •Subjects with diagnosis of osteoarthritis or traumatic arthritis
- •Subjects who demonstrate the ability to return for follow-up for the next 10 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 with avascular necrosis
- •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.
研究组 & 干预措施
1
Total hip Arthroplasty E-Poly™ liner in a titanium plasma sprayed RingLoc® shell
干预措施: Total Hip Arthroplasty (Procedure)
2
Total hip Arthroplasty ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell
干预措施: Total Hip Arthroplasty (Procedure)
3
Total hip Arthroplasty E-Poly™ liner with Regenerex Ringloc +™ shell
干预措施: Total Hip Arthroplasty (Procedure)
4
Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell
干预措施: Total Hip Arthroplasty (Procedure)
结局指标
主要结局
Survivorship: length of time implant remains without revision
时间窗: Evaluated at 1,3,5,7 ,10th year over 10 years
Complications and Adverse Events
时间窗: Evaluated at 1,3,5,7 ,10th year over 10 years
Incidence of radiolucencies (acetabular component)
时间窗: Evaluated at 1,3,5,7 ,10th year over 10 years
Patient administered Outcome Survey scores
时间窗: Evaluated at 1,3,5,7 ,10th year over 10 years
Polyethylene wear rates from AP radiographs
时间窗: Evaluated at 1,3,5,7 ,10th year over 10 years
次要结局
- Survivorship in subcategories of infection, aseptic loosening and other(1,3,5,7,10 yr over 10 years)
- Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life.(1,3,5,7,10 yr over 10 years)
- Other outcomes that may be relevant.(1,3,5,7,10 yr over 10 years)
- Retrieval analysis(1,3,5,7,10 yr over 10 years)
研究者
Henrik Malchau
Director of Reseach
Massachusetts General Hospital