This study is in response to the Food and Drug Administration (FDA) call to all manufacturers with 510(k) clearance for metal-on-metal (MoM) total hip arthroplasty (THA) devices to conduct postmarket surveillance studies. MicroPort has various acetabular shells, acetabular liners, fixation screws, femoral heads, femoral stems, modular necks, and proximal bodies currently cleared for MoM indications. Together these components comprise the Wright Medical Technology (WMT) MoM THA System. The primary objective of the study is to determine the incidence of adverse local tissue reactions (ALTR) in each THA implanted with the WMT MoM THA System overall and to create cross-sectional epochs of ≤ 8 years and \> 8 years, since implantation.
Study Type
OBSERVATIONAL
Enrollment
173
Subjects in Group 1 previously implanted prior to the study start date will be identified from Investigator records. Collected data will be evaluated in aggregate and cross-sectioned by year of implantation. Subjects will be cross-sectioned by the time that has elapsed between implantation and the initial visit (e.g. 5 years, 6 years) using contiguous visit windows (number of years + 6 months). Subject data will be grouped in order to create cross-sectional epochs of ≤ 8 years and \> 8 years.
TriWest Research Associates
El Cajon, California, United States
BioSolutions Research Center
La Mesa, California, United States
University of Iowa
Iowa City, Iowa, United States
Spokane Joint Replacement Center, Inc.
Spokane, Washington, United States
Rate of Adverse Local Tissue Reactions (ALTR)
To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1)
Time frame: ≤ 8 years and > 8 years, since implantation
Determine chromium and cobalt whole blood and serum ion levels across time intervals
Cobalt and chromium metal ion levels will be measured in whole blood and serum from subjects implanted with the WMT MoM THA System (Group 1) at each defined cross-section interval.
Time frame: ≤ 8 years and > 8 years, since implantation
Establish baseline for chromium and cobalt whole blood and serum ion levels across time intervals
Analyze difference in chromium and cobalt whole blood and serum ion levels in subjects implanted with the WMT MoM THA System (Group 1) versus control subjects (Group 2) cross-sectionally.
Time frame: ≤ 8 years and > 8 years, since implantation
Compare functional outcomes of subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).
Calculate and compare composite hip outcomes scores, via the validated HOOS scores, in Group 1 subjects with ALTR versus Group 1 subjects without ALTR
Time frame: ≤ 8 years and > 8 years, since implantation
Compare cobalt and chromium metal ion levels in subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).
Analyze difference in cobalt and chromium metal ion levels from Group 1 subjects with ALTR versus Group 1 subjects without ALTR
Time frame: ≤ 8 years and > 8 years, since implantation
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