Safety and feasibility of Poly Aryl Ether Ketone (PAEK) Implant for Contour Restoration in Jaw Reconstruction. A Pilot Trial

The use of Poly Aryl Ether Ketone (PAEK) contouring implant will be offered to participants who are undergoing fibula free flap reconstruction of the mandible where there is a > 10 mm deficit in the mandible contour that would normally (without the PAEK implant) result in asymmetry. PAEK contouring implant will be manufactured to match participant’s jaw contour using computer aided design and computer aided manufacturing. Participants will be asked to participate in the following interventions: Intervention • Appointment 1 (4 - 8 weeks prior to Baseline visit and Approximately 1 hour duration): - Informed consent - Medical History and Clinical History - Administration of quality of life questionnaire (Face Q) - 3D optical facial scan - CT scans of facial bones and fibula and intraoral scan of dentition as per standard of care. • Appointment 2 (Baseline 8-10 hours and Approximately additional 30-45 minutes duration during the standard fibula free flap reconstruction of the mandible): - Permanent implantation of PAEK contouring implant during fibula free flap reconstruction of the mandible - Participants will have PAEK contouring implant permanently - The surgical procedures will be exactly the same as a standard fibula flap reconstruction with only addition of fixation of the PAEK implant with titanium screws to the residual mandible and fibula flap. Follow up • Daily post operatively during participant's hospital admission (Approximately 15 minutes duration): - Assessment of treatment related adverse event • Day 14 post operation (Approximately 15 minutes duration): - Assessment of treatment related adverse event • Day 28 post operation (Approximately 15 minutes duration): - Assessment of treatment related adverse event • 3 months (Approximately 30 minutes duration): - Assessment of treatment related adverse event - Administration of quality of life questionnaire (Face Q) - 3D optical facial scan - CT scans of facial bones (standard of care) • 6 months (Approximately 30 minutes duration): - Assessment of treatment related adverse event - Administration of quality of life questionnaire (Face Q) - 3D optical facial scan - CT scans of facial bones (Standard of care) • At 12 months and then 12 monthly for 5 years (Approximately 30 minutes duration): - Assessment of treatment related adverse event - Administration of quality of life questionnaire (Face Q) - 3D optical facial scan - CT scans of facial bones (Standard of care) Intervention will be delivered face to face in the hospital clinic/operative theatre by a qualified reconstructive surgeon. There is no requirement for assessment of adherence. The design of PAEK contouring implant will conducted under a specific protocol to maintain the fidelity of intervention.