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

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ClinicalTrials.gov Identifier: NCT02174965
Recruitment Status : Recruiting
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Collaborators:
Corin
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Device: MiniHip (Corin U.K.) Device: Metafix (Corin, U.K) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RSA-measured in Vivo Wear, Migration and Micromotion in the Corin Mini-Hip/Metafix and ECIMA Polyethylene.
Study Start Date : September 2012
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MiniHip (Corin U.K.)
MiniHip (Corin U.K.) femoral component
Device: MiniHip (Corin U.K.)
MiniHip (Corin U.K.) femoral component

Active Comparator: Metafix (Corin, U.K)
Metafix (Corin, U.K) conventional cementless stem
Device: Metafix (Corin, U.K)
Metafix (Corin, U.K) conventional cementless stem




Primary Outcome Measures :
  1. Radiostereometric Analysis (RSA) measured migration (mm) [ Time Frame: 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 :
  1. Dynamically Inducible Micromotion DIMM (mm) [ Time Frame: Measured at 6, 12, 24 and 36 months post-operatively ]
    Using RSA this compares standard images with images taken in a single leg stance.

  2. Implant failure for femoral and acetabular components [ Time Frame: Observed at 3, 6, 12, 18, 24 and 36 months post-operatively ]
    Follow up assessment will monitor for signs of implant failure.

  3. Change in Oxford Hip Score [ Time Frame: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively ]
    A PROM to assess patient benefit.

  4. Change in Harris Hip Score [ Time Frame: 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 Outcome Measures:
  1. DEXA Scan [ Time Frame: Pre-operatively (baseline) and at 12 months post-operatively ]
    To monitor for peri-prosthetic changes in bone density following surgery



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174965


Contacts
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Contact: John Broomfield john.broomfield@ndorms.ox.ac.uk
Contact: Alice Harin alice.harin@ouh.nhs.uk

Locations
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United Kingdom
Nuffield Orthopaedic Centre Recruiting
Oxford, United Kingdom, OX3 7LD
Contact: John Broomfield       john.broomfield@ndorms.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
Corin
Oxford University Hospitals NHS Trust
Investigators
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Principal Investigator: Sion Glyn-Jones, MA MBBS MRCS FRCS University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02174965    
Other Study ID Numbers: MiniHip
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases