None listed
Conditions
Brief summary
The research project aims to evaluate safety and tolerability of a novel method for large volume bone reconstruction that includes a combination of a thin layer of bone with its blood supply kept in tact as well as a 3-D printed scaffold to help bone grow. This method of “growing” new bone uses a 3D printed substance similar to human bone and is already TGA approved for use in reconstruction of the bone of the skull. The novelty to the project stems from a new method of "growing" new bone in the patient by using a small amount of their own bone from another part of the body with its blood supply kept in tact using very fine surgical techniques (microsurgery) to connect the vessels. This approach is known in reconstructive surgery as a "free flap". It is hoped that this trial will provide further evidence to support the use of this method in reconstructing large segment bone loss for a range of conditions where minimal options currently exist – the focus being on “limb salvage” where amputation can be avoided for a better functional and socially acceptable outcome for the patient.
Interventions
A medical-grade Polycaprolactone Tricalcium Phosphate (mPCL-TCP) 3D printed scaffold (Osteopore, Pty. Ltd. Singapore) will be used in this project. The device has FDA approval and has been used in a single selected case in Australia with Special Access Scheme TGA approval. This will be used alongside a free or pedicled tissue transfer of corticoperiosteal tissue to regenerate bone sufficient to bridge a critical sized bone defect in the lower limb. The corticoperiosteal flap surgical approach is
A medical-grade Polycaprolactone Tricalcium Phosphate (mPCL-TCP) 3D printed scaffold (Osteopore, Pty. Ltd. Singapore) will be used in this project. The device has FDA approval and has been used in a single selected case in Australia with Special Access Scheme TGA approval. This will be used alongside a free or pedicled tissue transfer of corticoperiosteal tissue to regenerate bone sufficient to bridge a critical sized bone defect in the lower limb. The corticoperiosteal flap surgical approach is already used in reconstructive surgery. The combination of the two methods for lower limb reconstruction is the novelty related to this trial. Briefly, for patients that meet eligibility criteria for segmental bone defect repair of the lower limb, a customised (personalised) 3D printed scaffold (Osteopore, Pty. Ltd. Singapore) will be manufactured based on preoperative imaging data. Implant-related pre-operative planning and simulated scaffold implantation training is performed by the surgical team in the weeks leading up to each surgery to optimize the surgical outcome. This is performed as a single 60-minute training session led by the research principal investigator Dr Michael Wagels at the Australian Center for Complex Integrated Surgical Solutions (ACCISS) located at the Translational Research Facility in Woolloongabba, Brisbane. At the Princess Alexandra Hospital, the patient will undertake surgical reconstruction of the lower limb defect through the use of the scaffold to match the bone that is lost, alongside vascularised tissue transfer (“free flap”) of corticoperiosteal tissue (“corticoperiosteal flap”) to be placed inside the scaffold to enhance bone regeneration (regenerative matching axial vascularisation). Additionally, a bone growth factor (bone morphogenic protein -7) will be impregnated inside the scaffold to enhance scaffold-based bone regeneration. A team of experienced surgeons will perform the surgery over a period of 8 hours. Clinical follow up will occur over a 36 month period after the initial reconstruction, and further surgical interventions may be required during this period to optimise the outcome (as is done normally in lower limb reconstruction).
Sponsors
Osteopore International Pty Ltd
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 80 Years
Healthy volunteers
No
Inclusion criteria
Men or women >18 years of age and <80 years of age Acquired intercalary defect of the femur or tibia Patients must be willing and able to comply with the study requirements Patients must be capable of providing valid (written and informed) consent
Exclusion criteria
Active infection of the limb at the time of study inclusion Absence or significant disability associated with contra-lateral weight-bearing limb Patient unwilling or unable to provide fully informed consent including patients with intellectual or mental impairment Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency Known severe concurrent or inter-current illness including: cardiovascular, respiratory or immunological) illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the primary investigator, compromise their safety or compliance or interfere with interpretation of study results Patient life expectancy < 36 months Patient unable or unwilling to comply with the treatment protocol
Outcome results
None listed