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

NCT ID: NCT02174965

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MiniHip (Corin U.K.)

MiniHip (Corin U.K.) femoral component

Group Type EXPERIMENTAL

MiniHip (Corin U.K.)

Intervention Type DEVICE

MiniHip (Corin U.K.) femoral component

Metafix (Corin, U.K)

Metafix (Corin, U.K) conventional cementless stem

Group Type ACTIVE_COMPARATOR

Metafix (Corin, U.K)

Intervention Type DEVICE

Metafix (Corin, U.K) conventional cementless stem

Interventions

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MiniHip (Corin U.K.)

MiniHip (Corin U.K.) femoral component

Intervention Type DEVICE

Metafix (Corin, U.K)

Metafix (Corin, U.K) conventional cementless stem

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corin

INDUSTRY

Sponsor Role collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sion Glyn-Jones, MA MBBS MRCS FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Nuffield Orthopaedic Centre

Oxford, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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John Broomfield

Role: CONTACT

Alice Harin

Role: CONTACT

Facility Contacts

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John Broomfield

Role: primary

Other Identifiers

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MiniHip

Identifier Type: -

Identifier Source: org_study_id

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