ISRCTN11320405
Completed
未知
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 sites60 target enrollmentNovember 27, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Joint UCL/UCLH/Royal Free Biomedical Research Unit (UK)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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