A world first 3D printed tibial implant: Recognising and managing the risk of ethical slippage at the boundary of research and clinical practice with respect to innovative technology

Dr Jenny Jones1

1Metro South Health, Brisbane, Australia, 2Princess Alexandra Hospital, Brisbane, Australia

The growth of innovative technologies through collaborative research is leading to increased ethical challenges within the clinical environment. Drawing on a recent case consultation, this paper addresses questions such as: is it ethical to offer a patient an unproven technology despite promising indications being present? And conversely, is it ethical to withhold such technologies? Furthermore, how can we, the clinicians, organisational leaders and clinical ethicists, ensure no slippage occurs in respect to the principles of informed consent and the researcher-clinician’s enthusiasm to “trial” an unproven technology on a vulnerable patient?

Background: Large bone defects are a reconstructive challenge. If extensive they may be considered unreconstructable. Limb amputation may be the only treatment option. Three-Dimensional printed biomaterials are an emerging technology for bone replacement. Encouraging results have been achieved by combining this technology with living biological material in an animal model.

Methods: An adult male with an acquired 34cm tibial defect was referred to our institution’s complex lower limb clinic. At that time, preliminary results of three-dimensional printed models, combined with living tissue that has regenerative capacity in long segment bone defects using an aged sheep model, were available in consultation through our preclinical research collaborators. These results, though encouraging, were inconclusive.

Results: Following consultation with our Clinical Ethics Committee, the patient underwent tibial reconstruction in a 14 hour procedure on the 24/8/2017. There were no immediate or early post-operative complications. The patient was discharged on post-operative day 14. His first follow-up CT scan show an impressive volume of regenerate bone in the proximal reconstruction. This is the most extensive bone reconstruction performed to date.

Conclusion: Whilst the surgery and its early results are remarkable, it is important to both recognise and manage the risk of ethical slippage at the boundary of research and clinical practices in respect to innovative technologies.


Biography:

Dr Jenny Jones is the Coordinator of the Metro South Clinical Ethics Service. The core functions of her role are to assist staff build their ethical capacity, knowledge and practice, provide practical support by way of Clinical Ethics Consultation, and support the ethical climate of the organisation. She is a member of the Metro South Clinical Ethics Committee, Metro South Human Research Ethics Committee, Children’s Health Queensland Clinical Ethics Consultation Service and Queensland Forensic and Scientific Services Human Ethics Committee. She is also an Adjunct Lecturer, School of Medicine, Griffith University.