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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
MiniHip (Corin U.K.) femoral component
Metafix (Corin, U.K) conventional cementless stem
Nuffield Orthopaedic Centre
Oxford, United Kingdom
RECRUITINGRadiostereometric Analysis (RSA) measured migration (mm)
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.
Time frame: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Dynamically Inducible Micromotion DIMM (mm)
Using RSA this compares standard images with images taken in a single leg stance.
Time frame: Measured at 6, 12, 24 and 36 months post-operatively
Implant failure for femoral and acetabular components
Follow up assessment will monitor for signs of implant failure.
Time frame: Observed at 3, 6, 12, 18, 24 and 36 months post-operatively
Change in Oxford Hip Score
A PROM to assess patient benefit.
Time frame: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Change in Harris Hip Score
A clinician recorded outcome score to assess functional improvement.
Time frame: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
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