Flapless Zygomatic Implants Robot-assisted Placement (ROSA-ZYGOMA)

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

Zygomatic Implant

Robotic

Treatments

Procedure: Zygomatic implants

Study type

Interventional

Funder types

Other

Identifiers

NCT05565157

PI2020_843_0076

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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