45
Participants
Start Date
August 1, 2009
Primary Completion Date
May 22, 2023
Study Completion Date
May 22, 2023
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels
Analyses was performed pre-operatively, 6 months, 1 year, 2 years and 5 years post-operatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations was analysed by an approved Central Laboratory. The Central Laboratory provided specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory provided the results to the Investigators. The cobalt and chromium was measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden, Dresden
Lead Sponsor
Zimmer Biomet
INDUSTRY