Abnormalities, Jaw, Malocclusion, Angle Class III
Conditions
Brief summary
The study product is a Cold Ablation Robot-guided Laser Osteotome (CARLO®) robotic surgery device. It is a device that removes hard tissue such as bone by means laser ablation - it is therefore an alternative to Piezo-Electric osteotomes and/or oscillating saws or other mechanical instruments for bone cutting. In this study, the CARLO device is integrated with a computer-assisted pre-operative planning and intra-operative navigation, and will be used for Patients requiring an orthognathic procedure with a mid-face osteotomy, for whom a procedure plan is defined based on preoperative imaging.
Detailed description
The objective of this first-in-man study is to confirm the performance and safety of the CARLO® robotic surgery device (manufactured by Advanced Osteotomy Tools SA) for the execution of preoperatively planned midface osteotomies. The study is designed and powered to confirm, in clinical use across multiple sites, that the CARLO® device can be used to accurately perform straight-line mid-face osteotomies according to preoperative plans, and with results and a safety profile that are comparable to current state-of-the-art osteotomy methods. Multiple risk mitigations are in place to ensure safety, especially for the initially enrolled patients. A postoperative follow-up of up to 28 days will be included in this study, in order to assess initial soft tissue healing and recovery, and to enable the identification of any soft-tissue injuries that would not have been immediately apparent. After end of study of each individual patient, safety monitoring will go on for the duration of the study until the last visit of the last patient.
Interventions
DEVICEMid-face osteotomy
The mid-face osteotomy - typically according to LeFort I - is performed using a pulsed erbium-doped yttrium aluminium garnet (Er:YAG) laser driven by the CARLO robot arm.
Sponsors
Clinical Trial Unit, University Hospital Basel, Switzerland
Advanced Osteotomy Tools (AOT) AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study design is a prospective, bi-national, multi-center (3 centers), open-label single arm, confirmatory clinical study - with an initial explorative sequential phase.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\[ Indication for performing a mid-face osteotomy using a transoral approach, and suitability for use of CARLO® system: \] 1. Surgical relocation of the maxilla is indicated, using a mid-face osteotomy via a transoral approach that can be performed using bilateral straight-cut lines (LeFort I). Patients for whom a concomitant re-positioning of the mandibula or other corrections are indicated may be included in the study, as long as these corrections do not affect the repositioning of the maxilla that is being assessed; these additional osteotomies will not be performed using the CARLO® system. \[ General requirements related to enrollment in a clinical study \] 2. Patient is willing and able to attend all scheduled visits and comply with all study procedures 3. Aged ≥18 4. Ability to understand and give study-specific informed consent 5. Written informed consent obtained from patient \[ General precondition for orthognathic surgery \] 6. Proven completion of the facial growth
Exclusion criteria
\[ General contraindications related to enrollment in a clinical study \] 1. Female patients who are pregnant or breast feeding or are planning to become pregnant during the study 2. Other patients who are vulnerable persons, such as adults lacking the capacity in the consent procedure, patients in emergency situations. 3. Known or suspected non-compliance, drug or uncontrolled alcohol abuse. 4. Presence of any condition or abnormality that in the opinion of the Investigator of the Investigator would compromise the safety of the patient or quality of the data 5. The patient is participating in, or intends to participate in another investigational drug or device clinical trial within 12 months after enrollment 6. Enrolment of the Investigator, his/her family members, employees and other dependent persons \[ General contraindications for orthognathic surgery \] 7. Missing indication for orthognathic surgery 8. Patients with bleeding diathesis or coagulopathy 9. Patients with increased perioperative airway risk factors due to anatomical structures which limits usage of endotracheal intubation 10. Patients with intolerance or hypersensitivity to local anesthetics 11. Patients with consumptive/malignant primary disease (e.g. renal failure, hepatic dysfunction, severe heart failure, etc.) and a life expectancy of \< 6 months 12. Patients that have an odontogenic osteomyelitis 13. Patients that have a diagnosed bone metabolism disorder e.g. Osteoporosis, Osteomalacia, Paget's disease, renal osteodystrophy, parathyroid disorders 14. Patients who have received or are receiving antiresorptive therapy (bisphosphonates). 15. Patient has previously undergone radiotherapy in the region of the intended osteotomy 16. Patients with impaired wound healing, for example due to Type II diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RMS error during registration of in-situ patient with pre-operative model | Intra-operative observation | Point-pair matching performed to match preoperative imaging with the in-situ patient could be completed with a Root Mean Square error that does not exceed 1.5 mm. |
| Technical Success of Device Use | Upon completion of the procedure | Successful use of the device through all required steps: initial set-up and self-test, selection of each osteotomy path, previsualization of the path, completion of the osteotomies, and system shut down. |
| Position of the performed osteotomies is within 2 mm of the preoperatively planned location. | Intra-operative observation | The postion of the performed osteotomies is measured intraoperatively, relative to (orthogonally located) landmarks selected on the preoperative 3D model. The oucome is successful if this distance does not exceed 2 mm. |
| Successful completion of the maxillary downfracture and procedure without unusual difficulties. | Intra-operative observation | The maxillary mobilization (pterygo-maxillary disjunction, pull-down fracture) can be completed as usual. No difficulty is encountered that is unusual for the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the execution of the planned osteotomy based on postoperative imaging | Assessed ~2 weeks postoperatively based on postoperative imaging (CBCT) | Accuracy of the performed cut measured on postoperative CT (distance of the cut start and end relative to the incisor point and to the ipsilateral mesio-buccal cuspid, respectively). Target is to perform cut within 2 mm of the planned position. |
| Key variables of the osteotomy procedures (durations) | Upon completion of the procedure | Variables assessed include: 1. Duration of overall osteotomy procedure (first skin incision to skin closure). 2. Duration of patient registration with the CARLO® device (from on-screen selection of first point to be matched to display of an accepted Root Mean Square Error value). 3. Duration of CARLO® device cutting for each osteotomy. |
| Accuracy of the final maxilla location, compared to plan, based on postoperative imaging | Assessed ~2 weeks postoperatively based on postoperative imaging (CBCT) | Accuracy of the maxilla relocation, comparing on CT imaging the position of five defined landmarks (e.g. incisor point, tips of the upper canines, tips of the mesio-buccal cuspid) between the plan and the final result. |
| Absence of unusual complications that delay initial patient discharge. | 1 week post-procedure | Overall well-being of the patient allows a normal discharge from the hospital without unusual delay (within one week). |
| Absence of unusual soft tissue healing difficulties (14 days status). | 2 weeks post-procedure | During the visit scheduled at 14 days, soft tissue healing allows the removal of stitches as normally possible. |
| Absence of healing anomalies during final visit (28 days status) | 4 weeks post-procedure | During the visit scheduled at 28 days, absence of any anomaly or concern related to post-operative healing. |
Countries
Austria, Germany, Switzerland
Outcome results
None listed