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

University of Oxford

Status: Unknown

Conditions: Hip Osteoarthritis

Treatments: Device: MiniHip (Corin U.K.); Device: Metafix (Corin, U.K)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02174965

MiniHip

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

MiniHip (Corin U.K.)

Experimental group

Description:

MiniHip (Corin U.K.) femoral component

Treatment:

Device: MiniHip (Corin U.K.)

Metafix (Corin, U.K)

Active Comparator group

Description:

Metafix (Corin, U.K) conventional cementless stem

Treatment:

Device: Metafix (Corin, U.K)