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With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.
Our project aims to study the performance and safety of custom-made implants (custom-made guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthognatic surgery | Orthognathic surgery patients, adults or minors whose bone maturity is sufficient according to the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom-made guides and plates | Device | Patients will be included in the study and then followed clinically according to the routine care of orthognathic surgery with custom-made guides and plates. The only specific act of this study is the completion of an OQLQ quality of life questionnaire by patients preoperatively and between 8 to 12 months postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Orthognatic quality of life questionnaire | To evaluate the performance of custom-made implants indicated for orthognathic surgery by measuring the quality of life of patients | 12 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon satisfaction on the implant's utilisation | Assessment by a satisfaction questionnaire, specially developed for the study, completed by the surgeon after the surgery. The surgeon evaluates each item using a likert scale (Highly Satisfied/ Satisfied/ Not very satisfied / Unsatisfied). | Immediately following surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Orthognatic surgery male or female patients, adults or minors whose bone maturity is sufficient according to the judgment of the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet chirurgie Maxillo-faciale | Tournai | 7500 | Belgium | |||
| Cabinet Orhognatic |
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|
| Security of the implants used for orthognathic surgery |
Adverse events identification, assessment and follow-up. |
| 12 months |
| Lyon |
| 69005 |
| France |
| Hôpital de la Loire | Saint-Etienne | 42100 | France |
| Hôpital Villefranche sur Sâone | Villefranche-sur-Saône | 69655 | France |
| ID | Term |
|---|---|
| D001860 | Bone Plates |
| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |
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