Metal-on-metal Hip Prostheses: Do They Have Systemic Effects? (HipLink)
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|ClinicalTrials.gov Identifier: NCT02382835|
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : April 6, 2016
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.
|Condition or disease|
|Hip Replacement Heart Failure|
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 Type :||Observational|
|Actual Enrollment :||800000 participants|
|Observational Model:||Case Control|
|Official Title:||Metal-on-metal Hip Prostheses: Do They Have Systemic Effects?|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
|Metal-on-Metal Hip Replacement|
Other Hip Replacement
Other types of hip replacement, such as metal-on-polyethylene or ceramic-on-ceramic
- Heart failure [ Time Frame: 6 months onwards ]
- 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 ]
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): NCT02382835
|Royal National Orthopaedic Hospital|
|Stanmore, United Kingdom, HA74LP|