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Flapless Zygomatic Implants Robot-assisted Placement

Flapless Zygomatic Implants Robot-assisted Placement

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05565157
Acronym
ROSA-ZYGOMA
Enrollment
15
Registered
2022-10-04
Start date
2022-09-30
Completion date
2024-12-31
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Robotic, Zygomatic Implant

Keywords

zygomatic implant, robotic, flapless, mini-invasive, ROSA, immediate loading

Brief 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.

Interventions

A robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients suffering from Maxillary edentulism with severe bone resorption * Patients suffering from maxillary edentulism post maxillary defect (carcinologic or traumatic) and free flap reconstruction * Patients suffering from post-maxillectomy buccosinusal communication. * Age ≥ 18 years old * Having signed the informed consent

Exclusion criteria

* Patients suffering from chronic sinusitis * Patients refusing ROSA robot-guided surgery (unsigned informed consent). * Pregnant and nursing women

Design outcomes

Primary

MeasureTime frameDescription
Variation rate between theoretical intraoperative position and post-operative zygomatic implants positionone dayThe accuracy of zygomatic implants positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion.

Countries

France

Contacts

Primary ContactSylvie TESTELIN, Pr
sylvie.testelin@chu-amiens.fr03.22.08.90.50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026