A Provincial Initiative to Examine the Efficacy, Cost-effectiveness and Long-term Safety of Alternative Hip Bearing Surfaces Versus Conventional Therapy for Degenerative Joint Disease of the Hip
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,632
- 试验地点
- 1
研究概览
简要总结
A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement.
详细描述
This study is designed to provide orthopedic surgeons and decision makers with evidence-based health measures for patients that are treated by orthopedic surgeons for degenerative joint disease of the hip in Alberta. This study is provincial initiative to determine whether new alternative hip bearing surfaces improve patient outcomes and/or decrease health resource utilization in patients with degenerative joint disease of the hip in Alberta. The primary objective is to compare time to revision for patients receiving alternative hip bearing surfaces to patients receiving conventional total hip replacements. Secondary objectives are to evaluate long-term safety; to evaluate costs; to determine if alternative hip bearing surfaces improve patient function; to develop evidence base guidelines for the implementation of alternative hip bearing surfaces in Alberta; do develop a modal to assess other technologies and health advances; to develop an Alberta HIP registry
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documentation of DJD of hip
- •patient at least 18 years
- •patient able to provide written consent
- •Male under 65 years, female under 56 years
- •Orthopedic surgeon has received appropriate training to implant an alternative device
排除标准
- •renal failure (MOM only)
- •child bearing potential (MOM only)
- •inappropriate femoral anatomy, including evidence of osteoporosis
- •inflammatory arthritis (MOM)
- •Unwilling to consent
