Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-31 @ 3:41 AM
Study NCT ID:
NCT02382835
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2015-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metal-on-metal Hip Prostheses: Do They Have Systemic Effects?
Sponsor:
Royal National Orthopaedic Hospital NHS Trust
Organization:
Study Overview
Official Title:
Metal-on-metal Hip Prostheses: Do They Have Systemic Effects?
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HipLink
Brief 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.
We plan to link the National Joint Registry for England, Wales and Northern Ireland to the National Heart Failure Audit and GP records.
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:
1. History of treated or untreated acquired hypothyroidism (ICD9 244.8), or equivalent
2. Fracture history at a site distant to the ipsilateral hip (ICD9 820.00 to 826.1)
3. Acquired neurological disorders, including extra-pyramidal disorders (ICD9 332 and 333), spinocerebellar degenerative disease (ICD9 334) and other paralytic syndromes (ICD9 344)
4. Acquired blindness and low vision (ICD9 369)
5. 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.
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:
1. History of treated or untreated acquired hypothyroidism (ICD9 244.8), or equivalent
2. Fracture history at a site distant to the ipsilateral hip (ICD9 820.00 to 826.1)
3. Acquired neurological disorders, including extra-pyramidal disorders (ICD9 332 and 333), spinocerebellar degenerative disease (ICD9 334) and other paralytic syndromes (ICD9 344)
4. Acquired blindness and low vision (ICD9 369)
5. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: