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

Phase 1

• Conditions: Jaw reconstruction; Facial asymmetry; Head and neck cancer; Surgery - Surgical techniques; Cancer - Head and neck

• Registration Number: ACTRN12623001092684
• Lead Sponsor: Chris O'Brien Lifehouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-18
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

•18 years and older
•Head and neck cancer
•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
•Willingness to give informed consent

Exclusion Criteria

•Active soft tissue infection or osteomyelitis
•Less than 18 years of age
•Previously undergone renal or any other allogeneic transplantation and on high dose immunosuppressive therapy
•Unable to give informed medical consent due to cognitive impairment of psychiatric illness
•Current or recent drug and/or alcohol abusers
•On high dose immunosuppressive therapy including high dose steroids and methotrexate
•A history of an endocrine, connective tissue, or metabolic disorder known to severely affect osteogenesis (e.g., Paget’s Disease, renal osteodystrophy, Ehlers- Danlos Syndrome, or osteogenesis imperfecta)
•On other clinical trials who have received treatment with an investigational therapy within 28 days prior to reconstructive surgery or where treatment is planned during or after the follow up period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the rate of adverse event and complication compared to historical controls by clinical examination by reconstructive surgeon.[ At baseline, daily during the hospital admission after the surgery, Day 14, Day 28, 3 months, 6 months, 12 months and yearly for 5 years.];To assess radiological osseointegration of PAEK contouring implant compared to historical controls by clinical examination by reconstructive surgeon.[ 3 months, 6 months, 12 months and yearly for 5 years follow up.]

Secondary Outcome Measures

Name	Time	Method
Change in patient quality of life measure by Face Q questionnaire.[ Baseline, 3 months, 6 months, 12 months and yearly for 5 years follow up.];Change in volumetric assessment by optical facial scan [ Baseline, 3 months, 6 months, 12 months and yearly for 5 years follow up.];Change in volumetric assessment by CT scans of facial bones[ Baseline, 3 months, 6 months, 12 months and yearly for 5 years follow up.]