Hip Osteoarthritis
Conditions
Brief summary
The primary objective of this study is to determine whether the Mini Hip (Corin, U.K.) femoral component has a predictable and stable migration pattern (mean migration of the femoral component in three-dimensions,in mm) over a three year period, compared to a conventional cementless stem (Metafix, Corin, U.K.). The secondary objectives of this study are to determine whether the Trinity (Corin, U.K.) acetabular component has a predictable and stable migration pattern over a three year period and to measure the linear wear of femoral head into the ECIMA Highly Cross-linked polyethylene.
Interventions
DEVICEMiniHip (Corin U.K.)
MiniHip (Corin U.K.) femoral component
DEVICEMetafix (Corin, U.K)
Metafix (Corin, U.K) conventional cementless stem
Sponsors
Corin
Oxford University Hospitals NHS Trust
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women and men between the ages of 18 and 65 years old. * Scheduled to receive a hip replacement * Willing and able to give informed consent for participation in the study. * Diagnosed with hip osteoarthritis * Able (in the investigators opinion) and willing to comply with all study requirements. * Willing to allow his/her General Practitioner and consultant, if appropriate, to be notified of participation in the study
Exclusion criteria
The participants may not enter the study if ANY of the following apply: * Inflammatory arthropathy, osteoporosis or deformities of the proximal femur. * Significant comorbidities that would make follow up difficult or uncomfortable * Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk due to participation in the study, may influence the result of the study, or the participants ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiostereometric Analysis (RSA) measured migration (mm) | Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively | The images taken at each time point will be compared with the baseline to assess implant migration. Therefore the outcome is change in implant position measured using RSA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamically Inducible Micromotion DIMM (mm) | Measured at 6, 12, 24 and 36 months post-operatively | Using RSA this compares standard images with images taken in a single leg stance. |
| Implant failure for femoral and acetabular components | Observed at 3, 6, 12, 18, 24 and 36 months post-operatively | Follow up assessment will monitor for signs of implant failure. |
| Change in Oxford Hip Score | Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively | A PROM to assess patient benefit. |
| Change in Harris Hip Score | Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively | A clinician recorded outcome score to assess functional improvement. |
Other
| Measure | Time frame | Description |
|---|---|---|
| DEXA Scan | Pre-operatively (baseline) and at 12 months post-operatively | To monitor for peri-prosthetic changes in bone density following surgery |
Countries
United Kingdom
Contacts
Primary ContactJohn Broomfield
Backup ContactAlice Harin
Outcome results
None listed