Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component

NACompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

August 1, 2009

Primary Completion Date

May 22, 2023

Study Completion Date

May 22, 2023

Conditions
Avascular Necrosis of HipOsteoarthritis, HipRheumatoid ArthritisInflammatory ArthritisPost-traumatic; Arthrosis
Interventions
DIAGNOSTIC_TEST

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.

Trial Locations (1)

01307

Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden, Dresden

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Zimmer Biomet

INDUSTRY

NCT03681639 - Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component | Biotech Hunter | Biotech Hunter