Clinical Trial

Flapless Zygomatic Implants Robot-assisted Placement

Study acronym: ROSA-ZYGOMA
Unknown
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Record status
This record was last updated July 10, 2024 (before its estimated September 2024 completion). Its status may not reflect the trial's current state.
Summary
Zygomatic implants are indicated for the rehabilitation of the severely atrophic maxilla. Similar to standard implant placement, gaining an optimal position of the zygomatic implants is essential for a predictable prosthetic-driven treatment outcome. However, there is no effective mechanism to physically control the drilling trajectory for the zygomatic implants. Therefore, deviation between the actual and planned implant position is inevitable. This approach is technically difficult, and is performed by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics. In this project, a robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess. Path planning will be carried out on a pre-operative scanner. The ROSA robot (Zimmer®) will guide the several drillings steps. Placement of the zygomatic implant will be performed manually.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT05565157
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Conditions Zygomatic Implant, Robotic
Enrollment 15 participants
Start Date 2022-09-30
Primary Completion 2024-09 (estimated)
Study Completion 2024-12 (estimated)
Updated on ClinicalTrials.gov 2024-07-10