Cross-Sectional, Multi-Center Evaluation of 6 Year Metal Ion Trends for ASR-XL Total Hip Replacement System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 主要终点
- Change in Chromium serum ion level across time intervals
研究概览
简要总结
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the ASR-XL MoM system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to (or capable of) provide written, voluntary consent to participate in the clinical investigation,
- •Is willing and able to return for all protocol defined clinic visits,
- •Subject has (or had, if previously revised) a combination of the following implants in the study hip:
- •ASR-XL cup or ASR 300 cup
- •XL femoral head
- •ASR-XL tapered sleeve adapter
- •One of the following stems
- •i. S-ROM ii. Corail iii. Tri-Lock iv. AML v. Summit vi. Prodigy vii. C-Stem AMT
- •Subject has high quality films available for review that were taken within 12 months of primary surgery of the following views:
- •Standing AP-Pelvis
- •Standing AP-Proximal Femur (if this view is not available but the AP-Pelvis shows the entire implant and greater trochanter, that is also acceptable)
- •Lauenstien Lateral Proximal Femur (Lateral-femur).
排除标准
- •The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, the medical office staff and/or representatives from the FDA
- •The implanted hip components in the study hip (exclusive of cement), are not all DePuy components
- •The femoral component is the ASR hemi or some other hemi device.
结局指标
主要结局
Change in Chromium serum ion level across time intervals
时间窗: Pre-operatively through 6 years
To compare the chromium serum ion levels in the patient population from pre-operatively through 6 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (2 through 6 years) will be a different cohort of patients. Notes: Pre-operative values are being collected via a separate protocol. There is no 1 year data available for this product due its withdrawal from the market.
Change in Chromium whole blood ion level across time intervals
时间窗: Pre-operatively through 6 years
To compare the chromium whole blood ion levels in the patient population from pre-operatively through 6 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (2 through 6 years) will be a different cohort of patients. Notes: Pre-operative values are being collected via a separate protocol. There is no 1 year data available for this product due its withdrawal from the market.
Change in Cobalt whole blood ion level across time intervals
时间窗: Pre-operatively through 6 years
To compare the cobalt whole blood ion levels in the patient population from pre-operatively through 6 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (2 through 6 years) will be a different cohort of patients. Notes: Pre-operative values are being collected via a separate protocol. There is no 1 year data available for this product due its withdrawal from the market.
Change in Cobalt serum ion level across time intervals
时间窗: Pre-operatively through 6 years
To compare the cobalt serum ion levels in the patient population from pre-operatively through 6 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (2 through 6 years) will be a different cohort of patients. Notes: Pre-operative values are being collected via a separate protocol. There is no 1 year data available for this product due its withdrawal from the market.
次要结局
- Incidence of adverse local tissue reaction (ALTR)(Pre-operatively through 6 years post-operatively)
- To determine the association of adverse events with elevated ion levels(Through 6 years post-operatively)
- To identify the incidence of ALTR among unrevised subjects(Through 6 years post-operatively)
- Ion level change from first measurement for ALTR subjects(Through 6 years post-operatively)
- Poolability of data across stem types(Pre-operatively through 6 years post-operatively)
- Trending(Through 6 years post-operatively)
- Patient history and demographics and association with outcomes(Throughout 6 years post-operatively)
- Implant survivorship(Through 6 years post-operatively)
- Modes and causes of implant failure(Through 6 years post-operatively)
- Metal ion levels and association with reason for revision(Through 6 years post-operatively)
- Ion level vs. baseline for ALTR subjects(Through 6 years post-operatively)
- Ion levels among revised subjects(Pre-operatively through 6 years post-operatively)
- Harris Hip and HOOS analysis for pain, function and total score(Through 6 years post-operatively)
- Comparison of metal ion levels across subjects with vs. without ALTR(Through 6 years post-operatively)