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

Primary Purpose

Hip Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MiniHip (Corin U.K.)
Metafix (Corin, U.K)
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Nuffield Orthopaedic CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MiniHip (Corin U.K.)

Metafix (Corin, U.K)

Arm Description

MiniHip (Corin U.K.) femoral component

Metafix (Corin, U.K) conventional cementless stem

Outcomes

Primary Outcome Measures

Radiostereometric 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.

Secondary Outcome Measures

Dynamically Inducible Micromotion DIMM (mm)
Using RSA this compares standard images with images taken in a single leg stance.
Implant failure for femoral and acetabular components
Follow up assessment will monitor for signs of implant failure.
Change in Oxford Hip Score
A PROM to assess patient benefit.
Change in Harris Hip Score
A clinician recorded outcome score to assess functional improvement.

Full Information

First Posted
August 1, 2013
Last Updated
June 24, 2014
Sponsor
University of Oxford
Collaborators
Corin, Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02174965
Brief Title
Wear and Migration in the Corin Mini-Hip/Metafix and ECIMA Polyethylene
Acronym
MiniHip
Official Title
RSA-measured in Vivo Wear, Migration and Micromotion in the Corin Mini-Hip/Metafix and ECIMA Polyethylene.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Corin, Oxford University Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MiniHip (Corin U.K.)
Arm Type
Experimental
Arm Description
MiniHip (Corin U.K.) femoral component
Arm Title
Metafix (Corin, U.K)
Arm Type
Active Comparator
Arm Description
Metafix (Corin, U.K) conventional cementless stem
Intervention Type
Device
Intervention Name(s)
MiniHip (Corin U.K.)
Intervention Description
MiniHip (Corin U.K.) femoral component
Intervention Type
Device
Intervention Name(s)
Metafix (Corin, U.K)
Intervention Description
Metafix (Corin, U.K) conventional cementless stem
Primary Outcome Measure Information:
Title
Radiostereometric Analysis (RSA) measured migration (mm)
Description
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
Secondary Outcome Measure Information:
Title
Dynamically Inducible Micromotion DIMM (mm)
Description
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
Title
Implant failure for femoral and acetabular components
Description
Follow up assessment will monitor for signs of implant failure.
Time Frame
Observed at 3, 6, 12, 18, 24 and 36 months post-operatively
Title
Change in Oxford Hip Score
Description
A PROM to assess patient benefit.
Time Frame
Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Title
Change in Harris Hip Score
Description
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
Other Pre-specified Outcome Measures:
Title
DEXA Scan
Description
To monitor for peri-prosthetic changes in bone density following surgery
Time Frame
Pre-operatively (baseline) and at 12 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Broomfield
Email
john.broomfield@ndorms.ox.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Harin
Email
alice.harin@ouh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sion Glyn-Jones, MA MBBS MRCS FRCS
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nuffield Orthopaedic Centre
City
Oxford
ZIP/Postal Code
OX3 7LD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Broomfield
Email
john.broomfield@ndorms.ox.ac.uk

12. IPD Sharing Statement

Learn more about this trial

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

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