None listed
Conditions
Brief summary
• Purpose: To test a new method of jaw reconstruction that uses a custom implant in combination with a thin layer of bone with its own blood supply (a flap). This small flap, in combination with the implant is designed to allow for new bone to grow. The implant is designed to dissolve over time as it is replaced by new bone. As this is a new method, the main purpose of this trial is to assess for safety and tolerability of the implant. • Who is Running It? The Plastic and Reconstructive Surgery Department at Princess Alexandra Hospital, under the sponsorship of Metro South Health • Where & How Long? The surgery as well as follow up appointments will take place at the Princess Alexandra Hospital over a total duration of three years. • Ethics Approval: Approved by the Metro South Human Research Ethics Committee.
Interventions
This is a single arm feasibility trial. The intervention will involve the reconstruction of maxillary or mandibular defects with the surgical placement of a custom implant made of medical grade polycaprolactone and tricalcium phosphate,(mPCL-TCP) in combination with a corticoperiosteal free flap (CPF) that will be harvested from each participant. The mPCL-TCP implant will be designed using 3D segmentation software based on CT imaging (Materialise, Belgium). The mPCL-TCP implant will be manufact
This is a single arm feasibility trial. The intervention will involve the reconstruction of maxillary or mandibular defects with the surgical placement of a custom implant made of medical grade polycaprolactone and tricalcium phosphate,(mPCL-TCP) in combination with a corticoperiosteal free flap (CPF) that will be harvested from each participant. The mPCL-TCP implant will be designed using 3D segmentation software based on CT imaging (Materialise, Belgium). The mPCL-TCP implant will be manufactured, sterilised and shipped by the medical device company, Osteopore. A reconstructive surgeon will be administering the surgical intervention, with an estimated surgical duration of three hours. A CPF is a unit of tissue including cortical bone and periosteum that is harvested with its blood supply. Common sites of CPF harvest include the medial femoral condyle and the fibula. Following the surgical placement of the scaffold system, participants will attend regular followup appointment to assess for primary and secondary outcomes.
Sponsors
Metro South Hospital and Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Acquired defect of the maxilla or mandible. 2. Bone defect size that is less than one half of the tooth-bearing part of the maxilla/mandible. 3. Patient aged 18 years and over. 4. Patient willing and able to comply with the study requirements. 5. Patient or substitute decision maker capable of providing valid informed consent.
Exclusion criteria
1. Bone defect size that is more than one half of the tooth-bearing part of the maxilla/mandible. 2. Bone defects that include the condylar process of the mandible. 3. Patients who have undergone maxillectomy or mandibulectomy in the setting of ablative surgery for head and neck malignancy who have not had margin status confirmed. 4. Active infection of the mandible or maxilla at the time of study inclusion, demonstrated by a failed trial off antibiotics in chronic infected cases. 5. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency. 6. Known severe concurrent or inter-current illness including: cardiovascular, respiratory or immunological illness, psychiatric disorders, or alcohol or chemical dependence, and/or possible allergies that would, in the opinion of the primary investigator, compromise their safety or compliance or interfere with interpretation of study results. 7. Women who are currently pregnant or breast feeding. 8. Women of childbearing potential without an appropriate contraceptive method. 9. Patient life expectancy < 36 months. 10. Patient unable or unwilling to provide valid informed consent or comply with the treatment protocol.
Outcome results
None listed