Randomized Controlled Trial Comparison of Two Hydroxy-apatite Coated Hip Stems Utilizing Radiostereometric Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Migration
研究概览
简要总结
In this study, the investigators propose to randomize 80 subjects to receive either the Avenir cementless hip stem or a competing, HA-coated hip stem (Corail, DePuy-Synthes) and follow these patients for a period of 2 years post-surgery. The investigators aim to determine if the Avenir cementless hip stem has equivalent or better fixation and clinical outcomes compared to a predicate hip stem with longer clinical history.
详细描述
This is a multi-center, randomized controlled trial of patients undergoing primary total hip arthroplasty. This study will be focused on enrollment at a single site with possible expansion to additional centers should patient enrollment occur at a slower than expected rate. Decision to expand the study to additional centers will be mutually agreed upon by both the clinical site and the study sponsor.
Patients will be randomized to two study groups:
- Zimmer Avenir cementless, HA-coated femoral hip stem with matching Trilogy IT cup;
- DePuy-Synthes Corail cementless, HA-coated, non-collared femoral hip stem with matching Pinnacle cup Patient allocation to the study groups will occur following a randomized 4-block design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic osteoarthritis of the hip undergoing primary total hip arthroplasty
- •Between the ages of 18 and 79 inclusive
- •Patients willing and able to comply with follow-up requirements and self-evaluations
- •Ability to give informed consent
排除标准
- •Requires specialty implant (e.g., suspected metal allergy, coxa vera implant)
- •Avascular necrosis
- •Unresolved infection of the hip
- •Hip fracture
- •Hip dysplasia
- •At risk for loss to follow-up
- •Prior surgery to the ipsilateral hip
- •Severe proximal femoral deformity preventing the use of standard proximal press-fit femoral components
- •Medical condition precluding major surgery
- •Current or pending patient incarceration
结局指标
主要结局
Migration
时间窗: 2 years
Measured via radiosteriometric analysis
次要结局
未报告次要终点