Zygomatic ImplantROSA-ZYGOMANCT05565157
Flapless Zygomatic Implants Robot-assisted Placement
A study testing Zygomatic implants in people with Zygomatic Implant and Robotic, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zygomatic Implant, Robotic
- What is being tested?
- Zygomatic implants
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients suffering from chronic sinusitis
- Patients refusing ROSA robot-guided surgery (unsigned informed consent).
- Pregnant and nursing women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Sylvie Testellin, Pr, 03 22 08 90 50, testelin.sylvie@chu-amiens.fr
Jérémie BETTONI, MD
About this study
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.
Read more
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.
- Conditions
- Zygomatic Implant, Robotic
- Being tested
- Zygomatic implants
- Keywords
- zygomatic implant, robotic, flapless, mini-invasive, ROSA, immediate loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zygomatic implantsProcedure or surgery
A robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start30 Sep 2022
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomatic ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565157
- Sponsor's protocol ID
- PI2020_843_0076
- Acronym
- ROSA-ZYGOMA
- Status last verified
- Jul 2024
- First submitted
- 30 Sep 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flapless Zygomatic Implants Robot-assisted Placement
- ClinicalTrials.gov ID
- NCT05565157
- Acronym / sponsor ID
- ROSA-ZYGOMA / PI2020_843_0076
- Conditions
- Zygomatic Implant, Robotic
- Keywords
- zygomatic implant, robotic, flapless, mini-invasive, ROSA, immediate loading
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patients suffering from chronic sinusitis
- Patients refusing ROSA robot-guided surgery (unsigned informed consent).
- Pregnant and nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zygomatic implantsA robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess | Procedure or surgery | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Zygomatic Implant
Active, not recruiting
Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.
Implant Stability
Not yet recruiting
Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant
Severe Maxillary Atrophy
Enrolling by invitation
Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws
Orthodontic Anchorage Procedures
Recruiting
Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap
Atrophic Edentulous Maxilla, Zygomatic Implants
Recruiting
Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla
Atrophic Edentulous Maxilla, Zygomatic Implants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zygomatic implants in people with Zygomatic Implant and Robotic, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvie TESTELIN, Pr (03.22.08.90.50, sylvie.testelin@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation rate between theoretical intraoperative position and post-operative zygomatic implants position (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.