Non-Randomized, Multi-Site, Post-Market Study of the ICONACY I-Hip System (Protocol No. PS-1001)
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Radiographic Success as a Measure of Radiolucency and Component Migration
研究概览
简要总结
The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total hip replacement surgery.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A candidate for primary hip replacement on this operative hip.
- •Is 30 to 80 years of age.
- •Has hip joint disease related to one or more of the following:
- •Degenerative joint disease, (including osteoarthritis or post-traumatic arthritis)
- •Avascular Necrosis (AVN).
- •Will be available for evaluation for the duration of the study.
- •Is able and willing to speak and read English, read and sign the informed consent, fill out the WOMAC and Patient Satisfaction questionnaires, and follow all study procedures.
排除标准
- •Is younger than 30 years of age or older than 80 years of age.
- •Has undergone partial hip replacement or previous ORIF (open reduction internal fixation of femur or acetabulum).
- •Has undergone total hip replacement on this hip in the past (no revisions allowed in study).
- •Infection, or history of infection, acute or chronic, in the hip joint, or acute or chronic unresolved systemic infection.
- •Is currently experiencing radicular pain from the spine down operative leg.
- •Has participated in an IDE/IND clinical investigation with an investigational product in the last three months, or is involved in any personal injury litigation, medical-legal or worker's compensation claim.
- •Is a known drug or alcohol abuser or has a psychological disorder that could affect the ability to complete patient reported questionnaires.
- •Has been diagnosed with fibromyalgia or has a significant neurological or musculoskeletal disorder or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
- •Has been diagnosed with Paget's disease or Congenital hip deformity (dysplasia and/or dislocation).
- •Is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.)
- •Is Obese: (Defined for this study as having a BMI>45).
- •Has insufficient bone quality.
- •Has loss of ligamentous structures.
- •Has materials sensitivity.
- •Is currently a prisoner.
- •Is pregnant or lactating.
- •Has a contralateral amputation.
- •Has a medical condition with less than 2 years of life expectancy.
结局指标
主要结局
Radiographic Success as a Measure of Radiolucency and Component Migration
时间窗: 2 years
A subject will be considered a failure for Overall Radiographic Success if one or more of the below conditions are met: The subject will be considered a RADIOGRAPHIC FAILURE if: 1. there is a complete radiolucent line\> 3mm wide at the bone/cement interface or 2. there is a \>5 degree migration (shift) of the component or 3. there is a \>5 mm migration (shift) of the component.
Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered)
时间窗: 2 years
Patient satisfaction clinical assessment utilizing questionnaire
时间窗: 2 years
Clinical assessment of patient satisfaction will be made by utilizing a Patient Satisfaction (PS) questionnaire.
次要结局
- Revision of Implant Prosthesis as a Measure of Efficacy(5 years)