Hip OsteoarthritisMiniHipNCT02174965
Wear and Migration in the Corin Mini-Hip/Metafix and ECIMA Polyethylene
A study testing MiniHip (Corin U.K.) and Metafix (Corin, U.K) in people with Hip Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
Trial 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.). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- MiniHip (Corin U.K.) and Metafix (Corin, U.K)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
John Broomfield contact
Alice Harin contact
United Kingdom1 site, 1 recruiting
- Recruiting
Nuffield Orthopaedic Centre
Oxford, OX3 7LD
John Broomfield, john.broomfield@ndorms.ox.ac.uk
About this study
Official title: RSA-measured in Vivo Wear, Migration and Micromotion in the Corin Mini-Hip/Metafix and ECIMA Polyethylene.
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.
- Conditions
- Hip Osteoarthritis
- Being tested
- MiniHip (Corin U.K.), Metafix (Corin, U.K)
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniHip (Corin U.K.)Device
MiniHip (Corin U.K.) femoral component
Metafix (Corin, U.K)Device
Metafix (Corin, U.K) conventional cementless stem
| Study group | Role | What they receive |
|---|---|---|
| MiniHip (Corin U.K.) | Experimental | MiniHip (Corin U.K.) femoral component Receives: Device: MiniHip (Corin U.K.) |
| Metafix (Corin, U.K) | Active comparator | Metafix (Corin, U.K) conventional cementless stem Receives: Device: Metafix (Corin, U.K) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Secondary outcomes (4)
Dynamically Inducible Micromotion DIMM (mm)
Using RSA this compares standard images with images taken in a single leg stance.
Measured: Measured at 6, 12, 24 and 36 months post-operatively
Implant failure for femoral and acetabular components
Follow up assessment will monitor for signs of implant failure.
Measured: Observed at 3, 6, 12, 18, 24 and 36 months post-operatively
Change in Oxford Hip Score
A PROM to assess patient benefit.
Measured: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Change in Harris Hip Score
A clinician recorded outcome score to assess functional improvement.
Measured: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startSep 2012
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Corin, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Sion Glyn-Jones, MA MBBS MRCS FRCS, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174965
- Sponsor's protocol ID
- MiniHip
- Acronym
- MiniHip
- Status last verified
- Jun 2014
- First submitted
- 1 Aug 2013
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RSA-measured in Vivo Wear, Migration and Micromotion in the Corin Mini-Hip/Metafix and ECIMA Polyethylene.
- ClinicalTrials.gov ID
- NCT02174965
- Acronym / sponsor ID
- MiniHip / MiniHip
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Corin, Oxford University Hospitals NHS Trust
- Study start
- Sep 2012
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MiniHip (Corin U.K.) | Experimental | Device: MiniHip (Corin U.K.)MiniHip (Corin U.K.) femoral component |
| Metafix (Corin, U.K) | Active comparator | Device: Metafix (Corin, U.K)Metafix (Corin, U.K) conventional cementless stem |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiniHip (Corin U.K.)MiniHip (Corin U.K.) femoral component | Device | MiniHip (Corin U.K.) |
| Metafix (Corin, U.K)Metafix (Corin, U.K) conventional cementless stem | Device | Metafix (Corin, U.K) |
Primary outcome
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.
4 secondary outcomes
Dynamically Inducible Micromotion DIMM (mm)
Time frame: Measured at 6, 12, 24 and 36 months post-operatively
Implant failure for femoral and acetabular components
Time frame: Observed at 3, 6, 12, 18, 24 and 36 months post-operatively
Change in Oxford Hip Score
Time frame: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Change in Harris Hip Score
Time frame: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Broomfield contact
Alice Harin contact
Sion Glyn-Jones, MA MBBS MRCS FRCS principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiniHip (Corin U.K.) and Metafix (Corin, U.K) in people with Hip Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Broomfield (john.broomfield@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiostereometric Analysis (RSA) measured migration (mm) (time frame: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.