A Prospective Single Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System in Spain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Oxford Hip Score
研究概览
简要总结
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, involving the replacement of both the hip ball and socket. Its goal is to provide pain relief and enable the patient to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has an H-A.C. coating to promote osseointegration of the device within the host bone. To increase the surgeon's choice and thus suitability for the patient, there is the option of three different socket liners (ceramic, polymer, or dual mobility).
To ensure maximum safety and performance of medical devices, surveillance of the device should be carried out over the device's lifetime. This study is a 10-year surveillance study to assess the clinical, functional, and radiological outcomes of the CE-marked ACE Acetabular Cup System. This will be done by examining patient outcomes through questionnaires, reviews of X-rays, and recording any complications in patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients deemed suitable for elective primary THR, as per indications in the IFU.
- •Male or female, 18 years to 85 years.
排除标准
- •Patients who are unable to provide written informed consent.
- •Patients deemed unsuitable for THR, as per contra-indications in the IFU.
- •Patients indicated for THR as a result of trauma (i.e. neck of femur fracture).
- •Patients who are pregnant (exclusion criteria for THR in general).
- •Patients receiving implants other than the approved combination, i.e. an ACE Acetabular Cup System with a JRI femoral stem and head.
- •Patients who are unable to comply with the protocol.
结局指标
主要结局
Oxford Hip Score
时间窗: 3 years post-op
A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best)
次要结局
- Implant Survivorship(6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op)
- Oxford Hip Score(6 months, 1 year, 5 years, 7 years and 10 years post-op)
- Modified Harris Hip Score(6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op)
- EQ-5D-5L(6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op)
- Radiological Assessment(1 year, 5 years and 10 years post-op)