Hip ReplacementHipLinkNCT02382835
Metal-on-metal Hip Prostheses: Do They Have Systemic Effects?
An observational study of Hip Replacement and Heart Failure, run by Royal National Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
This study aims to determine whether subjects who underwent large-diameter metal-on-metal hip arthroplasty are more likely to have developed heart failure or other conditions as compared to subjects with conventional hip replacements. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Replacement, Heart Failure
- How many people
- 800,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Mar 2016
- 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: Description= Patients with a total hip replacement on the National Joint Registry that can be linked to either National Institute for Cardiovascular Outcomes Research (NICOR) or the Clinical Practice Research Datalink (CPRD) Geography = England Setting= Primary, Secondary and Tertiary care Dates = 1st April 2003 (the start of data collection for the National Joint Registry) to present
Who may be able to join
- Acceptable patients registered with an up to standard practice which participates in the CPRD linkage scheme.
- Have at least 6 (or 12) months of valid follow up in the primary care database.
- Primary or revision hip replacement on National Joint Registry (NJR) database occurring to during the period of availability of metal-on-metal implants, and during the available primary care follow up period for that patient.
- NHS number and other linkage identifiers available for both data sources
- Patient consent to NJR use of patient data (which is present for 99.6% of records on NJR)
Who cannot join
- Procedures on NJR database performed in Wales, Scotland and Northern Ireland (as these areas are not been included in the CPRD linkage scheme)
- Patients whose hips were implanted in the past 6 months - this exclusion criterion will be implemented post linkage of the data.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal National Orthopaedic Hospital
Stanmore, HA74LP
About this study
This study aims to determine whether subjects who underwent large-diameter metal-on-metal hip arthroplasty are more likely to have developed heart failure or other conditions as compared to subjects with conventional hip replacements.
We plan to link the National Joint Registry for England, Wales and Northern Ireland to the National Heart Failure Audit and GP records.
Read the detailed description
Background: Chronic systemic exposure to very high concentrations of cobalt or chromium following large diameter metal-on-metal hip resurfacing or hip replacement (MOMHR) associates with cardiac, thyroid, visual, hearing, and peripheral neurological deficits. Chronic exposure to lower circulating metal levels also associates with changes in cardiac function and bone metabolism in case-control analyses. However, it remains unclear what the risk of these problems is in the general population exposed to MOMHR.
Aims: We aim to establish the prevalence of cardiac, endocrine, neurological disorders, and distant site fracture history (forearm, spine) in recipients of MOMHR, and establish whether this differs to that found in the general population of the same age and sex distribution, and also to recipients of hip replacement using a conventional bearing.
Methods: We will use NJR data linked to the Clinical Practice Research Dataset (CPRD) to establish the prevalence of cardiac, endocrine, neurological disorders, and distant site fracture history (forearm, spine) in the 3 study populations.
Outcome measures: All defined as the event occurring at any point following MOMHR surgery.
Primary outcome measure:
History of cardiac failure, as defined by IDC9-CM code 150, or equivalent CPRD codes
Secondary outcome measures:
- History of treated or untreated acquired hypothyroidism (ICD9 244.8), or equivalent
- Fracture history at a site distant to the ipsilateral hip (ICD9 820.00 to 826.1)
- Acquired neurological disorders, including extra-pyramidal disorders (ICD9 332 and 333), spinocerebellar degenerative disease (ICD9 334) and other paralytic syndromes (ICD9 344)
- Acquired blindness and low vision (ICD9 369)
- Acquired hearing loss (ICD9 389)
Analyses will be conducted with age, sex, and joint disease diagnosis matching. Analyses will be stratified by sex to establish whether any differences are sex specific, and adjusted for age and other comorbidities, including history of type 2 diabetes, pre-existing ischaemic heart disease, hypertension, and pre-existing use of drugs that may affect cardiac function.
- Conditions
- Hip Replacement, Heart Failure
- Keywords
- metal-on-metal
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metal-on-Metal Hip Replacement | Not described | |
| Other Hip Replacement | Other types of hip replacement, such as metal-on-polyethylene or ceramic-on-ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure
Measured: 6 months onwards
Secondary outcomes (5)
History of treated or untreated acquired hypothyroidism or equivalent
Measured: 6 months onwards
Fracture history at a site distant to the ipsilateral hip
Measured: 6 months onwards
Acquired neurological disorders, including extra-pyramidal disorders spinocerebellar degenerative disease and other paralytic syndromes
Measured: 6 months onwards
Acquired blindness and low vision
Measured: 6 months onwards
Acquired hearing loss
Measured: 6 months onwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 800,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal National Orthopaedic Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Professor Alister Hart, Royal National Orthopaedic Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382835
- Sponsor's protocol ID
- 1
- Acronym
- HipLink
- Status last verified
- Apr 2016
- First submitted
- 3 Mar 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metal-on-metal Hip Prostheses: Do They Have Systemic Effects?
- ClinicalTrials.gov ID
- NCT02382835
- Acronym / sponsor ID
- HipLink / 1
- Conditions
- Hip Replacement, Heart Failure
- Keywords
- metal-on-metal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800,000 participants (actual)
- Lead sponsor
- Royal National Orthopaedic Hospital NHS TrustUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Mar 2015 (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.
This study aims to determine whether subjects who underwent large-diameter metal-on-metal hip arthroplasty are more likely to have developed heart failure or other conditions as compared to subjects with conventional hip replacements.
We plan to link the National Joint Registry for England, Wales and Northern Ireland to the National Heart Failure Audit and GP records.
Detailed description
Background: Chronic systemic exposure to very high concentrations of cobalt or chromium following large diameter metal-on-metal hip resurfacing or hip replacement (MOMHR) associates with cardiac, thyroid, visual, hearing, and peripheral neurological deficits. Chronic exposure to lower circulating metal levels also associates with changes in cardiac function and bone metabolism in case-control analyses. However, it remains unclear what the risk of these problems is in the general population exposed to MOMHR.
Aims: We aim to establish the prevalence of cardiac, endocrine, neurological disorders, and distant site fracture history (forearm, spine) in recipients of MOMHR, and establish whether this differs to that found in the general population of the same age and sex distribution, and also to recipients of hip replacement using a conventional bearing.
Methods: We will use NJR data linked to the Clinical Practice Research Dataset (CPRD) to establish the prevalence of cardiac, endocrine, neurological disorders, and distant site fracture history (forearm, spine) in the 3 study populations.
Outcome measures: All defined as the event occurring at any point following MOMHR surgery.
Primary outcome measure:
History of cardiac failure, as defined by IDC9-CM code 150, or equivalent CPRD codes
Secondary outcome measures:
- History of treated or untreated acquired hypothyroidism (ICD9 244.8), or equivalent
- Fracture history at a site distant to the ipsilateral hip (ICD9 820.00 to 826.1)
- Acquired neurological disorders, including extra-pyramidal disorders (ICD9 332 and 333), spinocerebellar degenerative disease (ICD9 334) and other paralytic syndromes (ICD9 344)
- Acquired blindness and low vision (ICD9 369)
- Acquired hearing loss (ICD9 389)
Analyses will be conducted with age, sex, and joint disease diagnosis matching. Analyses will be stratified by sex to establish whether any differences are sex specific, and adjusted for age and other comorbidities, including history of type 2 diabetes, pre-existing ischaemic heart disease, hypertension, and pre-existing use of drugs that may affect cardiac function.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal-on-Metal Hip Replacement | – | – |
| Other Hip Replacement | – | –Other types of hip replacement, such as metal-on-polyethylene or ceramic-on-ceramic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Description= Patients with a total hip replacement on the National Joint Registry that can be linked to either National Institute for Cardiovascular Outcomes Research (NICOR) or the Clinical Practice Research Datalink (CPRD) Geography = England Setting= Primary, Secondary and Tertiary care Dates = 1st April 2003 (the start of data collection for the National Joint Registry) to present
Key inclusion criteria (5 listed)
- Acceptable patients registered with an up to standard practice which participates in the CPRD linkage scheme.
- Have at least 6 (or 12) months of valid follow up in the primary care database.
- Primary or revision hip replacement on National Joint Registry (NJR) database occurring to during the period of availability of metal-on-metal implants, and during the available primary care follow up period for that patient.
- NHS number and other linkage identifiers available for both data sources
- Patient consent to NJR use of patient data (which is present for 99.6% of records on NJR)
Key exclusion criteria (2 listed)
- Procedures on NJR database performed in Wales, Scotland and Northern Ireland (as these areas are not been included in the CPRD linkage scheme)
- Patients whose hips were implanted in the past 6 months - this exclusion criterion will be implemented post linkage of the data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart failure
Time frame: 6 months onwards
5 secondary outcomes
History of treated or untreated acquired hypothyroidism or equivalent
Time frame: 6 months onwards
Fracture history at a site distant to the ipsilateral hip
Time frame: 6 months onwards
Acquired neurological disorders, including extra-pyramidal disorders spinocerebellar degenerative disease and other paralytic syndromes
Time frame: 6 months onwards
Acquired blindness and low vision
Time frame: 6 months onwards
Acquired hearing loss
Time frame: 6 months onwards
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 6 Apr 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Replacement and Heart Failure, run by Royal National Orthopaedic Hospital NHS Trust 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 5 inclusion and 2 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 6 Apr 2016. 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?
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?
Heart failure (time frame: 6 months onwards). 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 6 Apr 2016; AzTrials last refreshed its copy on 3 Nov 2026.