Patient Specific Osteosynthesis Trials
Orthognathic surgery, or corrective jaw surgery, aims to correct a wide range of skeletal or dental deformities and asymmetries. The surgery can include only the upper jaw (le Fort I osteotomy), solely the lower jaw (Bilateral Sagittal Split Osteotomy) or both jaws (a bimaxillary osteotomy). The accuracy of orthognathic surgery has improved over the past years, by the use of three-dimensional virtual planning (3D VSP).
The translation of this 3D planning towards the actual patient during surgery is performed using surgical splints (unique bite plate) and in combination with extra oral reference points measured by the surgeon. This method of translation from 3D VSP to surgical result is reported to fluctuate by >2mm.
Too much deviation from the optimal (3D) planned position of the jaw leads to insufficient results, such as remaining facial asymmetry, problems with dental occlusion or prolonged post-operative orthodontic treatments.
In the UMCG, a new method was developed for translation of the 3D VSP to the actual patient during surgery. The use of PSO enables accurate translation of the 3D VSP, without the need for the surgeon to manually contour the OSM and use a splint to position the upper jaw.
(Expected) advantages PSO project:
- More accurate translation of jaws in orthognathic surgery
- (Time) efficient: reduction of surgical time
- More stable fixation of the jaw/ reduction of post-operative relapse
- Definition of exact indications for use of PSO based on findings
- Dissemination/Regional spin-off: applications in other hospitals
- Number 1 position UMCG and Createch: no results published yet on clinical trials and indication for use
Deliverables:
- Multi-center Randomised controlled trial with application of PSO (intervention) and conventional OSM in the mandible-first surgical approach (control)
- Data on accuracy of both groups
- Definition of indications for use of the PSO
