Degenerative conditions of the hip requiring joint replacement Musculoskeletal Diseases Hip joint replacement
Conditions
Interventions
This study is a prospective, single centre, randomised controlled study. Patients will be randomly allocated to one of 2 treatment groups: the ‘investigation’ group will receive the TriFit cementless
Sponsors
Joint UCL/UCLH/Royal Free Biomedical Research Unit (UK)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the migration of the prosthesis at 2 years post-implantation by means of Radiostereometric Analysis (RSA). This will be measured using model-based RSA (MBRSA) methods with calculation of the overall translation and rotation of the implant at regular time-points. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study are: 1. Pattern of migration of the TriFit vs. POLARSTEM: baseline to 2-year post-procedure. 2. Assessment of micromotion (?inducible displacement?) at 6 weeks and 1 year post-implantation for TriFit vs POLARSTEM. 3. For both stems: Harris Hip Score, Oxford Hip Score and EQ5D pre-operatively, 6 months, 1 year and 2 years post-operatively 4. For both stems: Analysis of standard antero-posterior and lateral plain film radiographs taken post-operatively, 6 weeks, 6 months, 1 year and 2 years post-operatively 5. Incidence of adverse device effects and adverse events. | — |
Countries
England, United Kingdom
Outcome results
None listed