NCT02344160撤回不适用
A Prospective, Multi-center Consecutive Series Study of Subjects Treated With the REDAPT™ Revision Femoral System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Stem revision
研究概览
简要总结
The objective of the study is to demonstrate non-inferiority of stem revision rate in subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5 year mark assuming an observed rate of 6.5% at 5 years. Additional data will be collected as outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.
详细描述
This study is a prospective, multi-center, consecutive series study of subjects treated with REDAPT™. The safety and effectiveness of the REDAPT™ revision stem will be assessed over a maximum of 5 years with additional follow up to 10 years to assess outcomes. The objective of this study is to establish if the REDAPT™ stem revision rate is less than 9.8% at 5 years with an observed rate from literature review of 6.5% at 5 year.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject requires revision hip arthroplasty
- •Subject requires subsequent revision of a joint replacement that involves the insertion, removal and/or replacement of a prosthesis or implant
- •Subjects with inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
- •Treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
- •Endoprosthesis, femoral osteotomy, or Girdlestone resection
- •Subject is at least 18 years of age
- •Subject is skeletally mature in Investigators judgment
- •Subject is willing to consent to participate in the study
- •Subject is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk
排除标准
- •Known allergies to any components of the devices
- •Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation
- •Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits
- •Subject is facing current or impending incarceration
- •Female subject is of child-bearing age and not using an approved method of contraception
- •Mental or neurological conditions which could impair the subject's ability or willingness to comply with the study
- •Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.
- •Skeletal immaturity
- •Subject is severely overweight (BMI > 40)
结局指标
主要结局
Stem revision
时间窗: 5 years with additional follow up to 10 years
the primary outcome will be assessed by the incidence of stem revision
次要结局
- Hip Disability and Osteoarthritis Outcome Score (HOOS) and Euro Group Questionnaire (EQ-5D)(At baseline and up to 10 year follow up)
- Revision for any reason(5 years with additional follow-up to 10 years)
- Radiographic Measurements(post operatively with additional follow-up to 10 years)
- Harris Hip Score(at baseline and follow up visits up to 10 year follow up post surgically)
- Metal Ion measurement in whole blood(baseline and at each study visit up to 10 years following REDAPT REvison surgery.)
- Number of participants with Adverse Events(Adverse events will be collected and assessed as safety out come at each study visit up to 10 years post surgery)
研究者
研究点 (1)
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