Flapless Zygomatic Implants Robot-assisted Placement

Not Applicable

Recruiting

• Conditions: Zygomatic Implant; Robotic

• Registration Number: NCT05565157
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-30
• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Variation rate between theoretical intraoperative position and post-operative zygomatic implants position	one day	The accuracy of zygomatic implants positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France