Metal-on-metal Hip Prostheses: Do They Have Systemic Effects?
HipLink
1 other identifier
observational
800,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 3, 2015
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 6, 2016
April 1, 2016
1 year
March 3, 2015
April 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart failure
6 months onwards
Secondary Outcomes (5)
History of treated or untreated acquired hypothyroidism or equivalent
6 months onwards
Fracture history at a site distant to the ipsilateral hip
6 months onwards
Acquired neurological disorders, including extra-pyramidal disorders spinocerebellar degenerative disease and other paralytic syndromes
6 months onwards
Acquired blindness and low vision
6 months onwards
Acquired hearing loss
6 months onwards
Study Arms (2)
Metal-on-Metal Hip Replacement
Other Hip Replacement
Other types of hip replacement, such as metal-on-polyethylene or ceramic-on-ceramic
Eligibility Criteria
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
You may qualify if:
- 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)
You may not qualify if:
- Procedures on NJR database performed in Wales, Scotland and Northern Ireland (as these areas are not been included in the CPRD linkage scheme)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal National Orthopaedic Hospital
Stanmore, HA74LP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Orthopaedics
Study Record Dates
First Submitted
March 3, 2015
First Posted
March 9, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 6, 2016
Record last verified: 2016-04