Wear and Migration in the Corin Mini-Hip/Metafix and ECIMA Polyethylene

Not Applicable

• Conditions: Hip Osteoarthritis
• Interventions: Device: MiniHip (Corin U.K.); Device: Metafix (Corin, U.K)

• Registration Number: NCT02174965
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-08-01
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-24
• Last Update Submitted: 2014-06-24
• Study First Posted: 2014-06-26
• Last Update Posted: 2014-06-26
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MiniHip (Corin U.K.)	MiniHip (Corin U.K.)	MiniHip (Corin U.K.) femoral component
Metafix (Corin, U.K)	Metafix (Corin, U.K)	Metafix (Corin, U.K) conventional cementless stem

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nuffield Orthopaedic Centre; 🇬🇧 Oxford, United Kingdom