I. Purpose and Objective
This study has been designed to estimate the prevalence of soft tissue changes following primary THA surgery in patients having received one of two Biomet implant types; a MOP primary THA or Biomet MOM primary THA devices (M2a Ringloc, M2a Taper, M2a 38 or the M2a Magnum) in 308-436 total patients at four centers.
The primary objective of the study is to estimate the prevalence of soft tissue changes in unbiased MoM and MoP samples. Secondary objectives are to determine if the presence of metal ion concentrations generally increases over time and if those concentrations are related to anticipated or unanticipated adverse events, adverse local tissue reactions (ALTRs) or revision. To establish a baseline level of metal ions in a relevant population, 100 THA patients (25 consecutive at each center) will have metal ion levels tested in whole blood and in serum.
A fifth center will be added to the study protocol to assist with obtaining the magnum cohort.