An observational study in Hip Athroplasty Using M2a Magnum, sponsored by Zimmer Biomet. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-24.
Sponsored by Zimmer Biomet · Observational
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.
Patients receiving either the M2a Magnum or M2a 38mm Metal on Metal primary hip replacement devices from a single study centre.
Exclusion Criteria:
MRI Scoring change in soft tissue mass size
MRI Score - monitor number and size of soft tissue lesions
Time frame: 36 months after primary device implantation
Radiographic assessment
Assess acetabular cup inclincation and version
Time frame: 36 months after primary device implantation
Oxford Hip Score
Oxford Hip Score, score range 0 (worst) to 48 (best)
Time frame: 36 months after primary device implantation
UCLA Activity Score
UCLA activity scale, range: 1 defined as "no physical activity, dependent on others" to 10 defined as "regular participation in impact sports."
Time frame: 36 months after primary device implantation
EQ-5D
EQ-5D Index score; Patient Reported Outcome
Time frame: 36 months after primary device implantation
Metal Ion Levels
Chromium and Cobalt metal ion levels in blood
Time frame: 36 months after primary device implantation
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Zimmer Biomet