Metal Hip ReplacementNCT02262468
Warwick Metal On Metal Study
An observational study of Metal Hip Replacement, run by South Warwickshire NHS Foundation Trust.
Trial summary
assess results of metal on metal hip replacements carried out at warwick hospital Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metal Hip Replacement
- What is being tested?
- x ray
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Dec 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with 36mm metal on metal hips
Who may be able to join
- All patients with 36mm metal on metal hips
Who cannot join
- -
About this study
Official title: Review of 750 36mm MOM Hip Replacements ( Pinnacle/Corail) With up to 6 Year Follow up
assess results of metal on metal hip replacements carried out at warwick hospital
Read the detailed description
Resurfacing and XL head hip replacements have not done as well as expected. The ASR implant has been withdrawn. Recent publications and media appearances by Tony Nargol, an orthopaedic surgeon, have suggested 36mm metal on metal replacements. I intend to report the results of this series.
- Conditions
- Metal Hip Replacement
- Being tested
- x ray
- Keywords
- retrospective analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x rayRadiation
| Study group | Role | What they receive |
|---|---|---|
| MOM total hip replacements | all patients with MOM 36mm hip replacements Receives: Radiation: x ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford hip score
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metal Hip ReplacementStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Warwickshire NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy International
- Responsible party
- Principal investigator, Stephen Young, South Warwickshire NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262468
- Sponsor's protocol ID
- IIS2012012
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of 750 36mm MOM Hip Replacements ( Pinnacle/Corail) With up to 6 Year Follow up
- ClinicalTrials.gov ID
- NCT02262468
- Acronym / sponsor ID
- IIS2012012
- Conditions
- Metal Hip Replacement
- Keywords
- retrospective analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- South Warwickshire NHS Foundation TrustUniversity, hospital or other
- Collaborators
- DePuy International
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Oct 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.
assess results of metal on metal hip replacements carried out at warwick hospital
Detailed description
Resurfacing and XL head hip replacements have not done as well as expected. The ASR implant has been withdrawn. Recent publications and media appearances by Tony Nargol, an orthopaedic surgeon, have suggested 36mm metal on metal replacements. I intend to report the results of this series.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOM total hip replacements | – | Radiation: x rayall patients with MOM 36mm hip replacements |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with 36mm metal on metal hips
Key inclusion criteria (1 listed)
- All patients with 36mm metal on metal hips
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| x ray | Radiation | MOM total hip replacements |
Primary outcome
Oxford hip score
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metal Hip Replacement, run by South Warwickshire NHS Foundation Trust.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford hip score (time frame: 6 years). 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 13 Oct 2014.