MedTrace Logo

Metal-on-metal Hip Replacement MRI Study

NCT03409640 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-01-24

No results posted yet for this study

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

  • Hip Athroplasty Using M2a Magnum

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-17
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03409640 on ClinicalTrials.gov