Zimmer Biomet is prioritizing specific products within its portfolio and has chosen not to extend the CE mark for the GTS stem under MDR requirements, leading to the premature termination of the GTS study in 2024.
Summary
This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.
Protocol Amendment History
4 changes
criticalTrial terminated2026-08-11
criticalTrial terminated: Zimmer Biomet is prioritizing specific products within its portfolio and has chosen not to extend the CE mark for the G...2026-08-11
notablePrimary completion moved earlier: 2020-12 -> 2020-052026-08-11
minorCompletion moved earlier: 2028-09 -> 2025-052026-08-11