ACTRN12623001092684
Not Yet Recruiting
Phase 1
Safety and feasibility of Poly Aryl Ether Ketone (PAEK) Implant for Contour Restoration in Jaw Reconstruction. A Pilot Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Jaw reconstruction
- Sponsor
- Chris O'Brien Lifehouse
- Enrollment
- 12
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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