A Post-market Clinical Follow-up (PMCF) Study to Evaluate Clinical, Radiographic and Patient Reported Outcomes Following a Hip Hemiarthroplasty Surgery Using Corin Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Corin
- 入组人数
- 368
- 试验地点
- 4
- 主要终点
- Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery.
研究概览
简要总结
This PMCF study is designed to collect safety and efficacy data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.
详细描述
As part of the current clinical remediation work under the new Medical Device Regulation (MDR), limited data have been identified to support the hemiarthroplasty indication for some of Corin femoral stems. Therefore, this PMCF study has been implemented to collect safety and performance data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Both genders.
- •Adult subjects.
- •Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices based on physical examination, medical history and diagnosis such as: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, revision of failed partial hip replacements in which the acetabulum does not require replacement.
- •The subject is willing to comply with the required follow-up visits as per protocol.
- •The subject, or a designated trusted person in case the subject is unable to do, has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.
排除标准
- •Subjects with active infection or sepsis or osteomyelitis.
- •Subjects with unsuitable or insufficient bone support preventing proper fixation of the prosthesis.
- •Subject with marked bone loss or bone absorption.
- •Subject with metabolic disorders which may impair bone formation or bone quality.
- •Subjects under guardianship.
- •Subjects under jusicial protection
- •Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.
研究组 & 干预措施
Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+)
Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices
干预措施: Bipolar i and cemented stem (Océane+ or Meije) (Device)
结局指标
主要结局
Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery.
时间窗: 2 years
Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.
次要结局
- Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU.(10 years)
- Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU.(10 years)
- Evaluation of mid-term and long-term safety of the study devices up to 10 years.(10 years)
- Radiographic analysis to detect acetabular erosion(2 years)
- Radiographic analysis to detect femoral stem stability(2 years)
- Radiographic analysis to detect bipolar head migration(2 years)