Flapless Zygomatic Implants Robot-assisted Placement
ROSA-ZYGOMA
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2022
CompletedStudy Start
First participant enrolled
September 30, 2022
CompletedFirst Posted
Study publicly available on registry
October 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJuly 10, 2024
July 1, 2024
1.9 years
September 30, 2022
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Variation rate between theoretical intraoperative position and post-operative zygomatic implants position
The accuracy of zygomatic implants positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion.
one day
Interventions
A robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients suffering from chronic sinusitis
- Patients refusing ROSA robot-guided surgery (unsigned informed consent).
- Pregnant and nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80480, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2022
First Posted
October 4, 2022
Study Start
September 30, 2022
Primary Completion
September 1, 2024
Study Completion
December 1, 2024
Last Updated
July 10, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share