A prospective, randomised, single centre clinical study comparing stability of the cementless TriFit femoral stem versus the cementless POLARSTEM by radiostereometric analysis

Joint UCL/UCLH/Royal Free Biomedical Research Unit (UK)0 个研究点目标入组 60 人开始时间: 2014年11月27日最近更新: 2022年8月22日

试验速览

暂无简介。

•1. The surgeon and the patient must agree that primary total hip replacement (THR) is necessary
•2. The patient must be fit for the operation in the opinion of the surgeon and the interdisciplinary team
•3. The indication for primary THR must be primary osteoarthritis, avascular necrosis, femoral neck fracture, hip dysplasia, inflammatory arthritis
•4. Patients requiring primary arthroplasty only
•5. The TriFit / POLARSTEM implant is an acceptable choice of implant to match the patient?s anatomy (confirmed with acetate / digital templating)
•6. Patients must be aged between 18 ? 80 years at the time of surgery
•7. Sex: both male and female
•8. The patient must be capable of giving informed consent and express a willingness to comply with the post-operative review program
•9. The patient must be a permanent resident in an area accessible to the study site
•10. The patient must have sufficient post-operative mobility to attend follow-up clinics and allow for radiographs to be taken

•1. Patient not suitable for primary joint replacement e.g. requires arthrodesis (fusion) or revision (re-do) surgery
•2. Patient not fit for surgery
•3. Underlying cause for osteoarthritis separate from that included in inclusion criteria e.g. suspected infection, osteoporosis, osteomyelitis
•4. Patient younger than 18 years old or older than 80 years old
•5. Patient already enrolled in a clinical trial including other radiostereometric analysis study
•6. Post infection in affected hip
•7. Severe deformity in femur prohibiting the use of the proximally fitting implant
•8. The individual is unable or unwilling to sign the patient informed consent specific to this study
•9. Anticipated that the patient will lack sufficient mobility to attend follow up at Institute of Sport, Exercise and Health (ISEH)
•10. Patient non-resident in local area or expected to leave catchment area post-operatively

发起方

Joint UCL/UCLH/Royal Free Biomedical Research Unit (UK)