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ROSA-ZYGOMA: Flapless Zygomatic Implants Robot-assisted Placement

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05565157
Collaborator
(none)
15
Enrollment
1
Location
23.1
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Zygomatic implants
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Flapless Zygomatic Implants Robot-assisted Placement
Actual Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Amiens France 80480

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT05565157
Other Study ID Numbers:
  • PI2020_843_0076
First Posted:
Oct 4, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
zygomatic implant
robotic
flapless
mini-invasive
ROSA
immediate loading

Study Results

No Results Posted as of Oct 4, 2022