Status:
COMPLETED
Metal-on-metal Hip Replacement MRI Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Hip Athroplasty Using M2a Magnum
Eligibility:
All Genders
18+ years
Brief Summary
This study is being conducted to determine the rate of symptomatic and asymptomatic nonmalignant, noninfective soft tissue mass presence (referred to in the literature as pseudotumour, ALVAL, ARMD, cy...
Eligibility Criteria
Inclusion
- • Patients implanted with the M2a Magnum who were evaluated via MRI and metal ion analysis between 2012 and 2013.
Exclusion
- If the primary device was implanted for less than 36 months (in the case of patients already revised) or has been in place for less than 36 months (in the case of patients with the device still in place).
- If the patient is contraindicated for any of the diagnostic tests.
- If the patient fails to consent to participating in the study.
Key Trial Info
Start Date :
January 17 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03409640
Start Date
January 17 2014
End Date
December 31 2017
Last Update
January 24 2018
Active Locations (1)
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1
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom, RG24 9NA