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NCT Number: NCT05565157

Flapless Zygomatic Implants Robot-assisted Placement

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.

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Key information

Conditions

Zygomatic Implant Robotic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Jérémie BETTONI, MD

SUB_INVESTIGATOR

Matthieu OLIVETTO, MD

SUB_INVESTIGATOR

Michel LEFRANC, Pr

SUB_INVESTIGATOR

Sylvie Testellin, Pr

CONTACT

[email protected]

03 22 08 90 50

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zygomatic implants

Procedure

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

Primary outcomes

  1. Variation rate between theoretical intraoperative position and post-operative zygomatic implants position

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sylvie TESTELIN, Pr

CONTACT

[email protected]

03.22.08.90.50

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: ROSA-ZYGOMA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2022
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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