Heart Failure Clinical Trial
— HipLinkOfficial title:
Metal-on-metal Hip Prostheses: Do They Have Systemic Effects?
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.
Status | Completed |
Enrollment | 800000 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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. |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal National Orthopaedic Hospital | Stanmore |
Lead Sponsor | Collaborator |
---|---|
Royal National Orthopaedic Hospital NHS Trust | University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart failure | 6 months onwards | No | |
Secondary | History of treated or untreated acquired hypothyroidism or equivalent | 6 months onwards | No | |
Secondary | Fracture history at a site distant to the ipsilateral hip | 6 months onwards | No | |
Secondary | Acquired neurological disorders, including extra-pyramidal disorders spinocerebellar degenerative disease and other paralytic syndromes | 6 months onwards | No | |
Secondary | Acquired blindness and low vision | 6 months onwards | No | |
Secondary | Acquired hearing loss | 6 months onwards | No |
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