Trials / Completed
CompletedNCT03409640
Metal-on-metal Hip Replacement MRI Study
The Rate of Symptomatic and Asymptomatic Non-malignant, Non-infective Soft Tissue Masses in Primary Metal on Metal Hip Replacement.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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, cysts or lesions) in primary metal on metal hip replacement patients. The primary objective of the study is to determine the prevalence of masses in unbiased Metal on Metal (MoM) samples drawn from one study centre. The subjects receiving the Metal on Metal devices will be observed at two specific time points. Secondary objectives are to evaluate whether the occurrence of masses is related to any of several potential factors including patient and implant characteristics and time since the implant procedure took place.
Conditions
Timeline
- Start date
- 2014-01-17
- Primary completion
- 2017-12-31
- Completion
- 2017-12-31
- First posted
- 2018-01-24
- Last updated
- 2018-01-24
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03409640. Inclusion in this directory is not an endorsement.