Aim

The aim of this study is to outline the steps and techniques required to create a patient specific 3D printed guide for the accurate placement of the origin of the femoral tunnel for single bundle ACL reconstruction.

Many orthopaedic procedures require implants to be trialled before definitive implantation. Where this is required, the trials are provided in a set with the instrumentation. The most common scenario this is seen in during elective joint replacements. In Scotland (2007) the Scottish Executive (http://www.sehd.scot.nhs.uk/cmo/CMO(2006)13.pdf) recommended and implemented individually packed orthopaedic implants for all orthopaedic sets. The premise for this was to reduce the risk of CJD contamination and fatigue of implants due to constant reprocessing from corrosion. During many trauma procedures determining the correct length of plate or size of implant can be challenging. Trials of trauma implants is no longer common place. Many implants are stored in closed and sealed boxes, preventing the surgeon looking at the implant prior to opening and contaminating the device. As a result many implants are incorrectly opened and either need reprocessed or destroyed due to infection control policy, thus implicating a cost to the NHS. With even the simplest implants costing several hundreds of pounds, this cost is a very significant waste in resources that could be deployed else where. My project was to develop a method to produce in department accurate, cheap and disposable trials for implants often used in trauma, where the original manufacturer do not offer the option of a trial off the shelf. The process had to not involve contaminating or destroying the original implant in the production of a trial.

Several implants which are commonly used within Glasgow Royal Infirmary and do not have trials were identified. These implants were then CT scanned within their sealed and sterile packaging without contamination. Digital 3D surface renders of the models were created using free open source software (OsiriX, MeshLab, NetFabb). These models were then processed in to a suitable format for 3D printing using laser sintering via a cloud 3D printing bureau (Shapeways.com). The implants were produced in polyamide PA220 material or in 316L stainless steel. These materials could be serialized using gamma irradiation or ethylene oxide gas. The steel models were suitable for autoclaving in the local CSSU.

The implants produced were accurate facsimiles of the original implant with dimensions within 0.7mm. The implants were cost effective, an example being a rim mesh was reproduced in polyamide PA220 plastic for £3.50 and in 316L stainless steel for £15. The models were produced within 10 days of scanning. The stainless steel trials were durable and suitable for reprocessing and resterilisation.

The production of durable, low cost and functional implant trials all completed in department was successful. The cost of production of each implant is so low that it would be offset if just one incorrect implant was opened during a single procedure. With some of the implants tested, the trials would have paid for themselves 100 times. This is a simple and cost saving technique that would help reduce department funding and aid patient care.

3D printing an additive manufacturing technique, allowing for rapid prototyping in many industries. To date, medical applications have generally been within a research or industry environment, as the costs (expertise, software and equipment) have been prohibitive.

We have established a means by which 3D printing of bones can be achieved quickly, cost-effectively and accurately from standard computer tomography (CT) digital imaging and communications in medicine (DICOM) data.

CT DICOM data of a malunited forearm fracture were manipulated using open-source software (no cost) and a 3D model was produced by selective-laser-sintering. The entire process took 7 days (total cost £77). This process and the resultant model were then assessed for overall accuracy.

This sequential methodology provides ready and economical access to a technology that is valuable for preoperative templating/rehearsal in complex 3D reconstructive cases.

Rapid prototyping (RP), especially useful in surgical specialities involving critical three-dimensional relationships, has recently become cheaper to access both in terms of file processing and commercially available printing resources.

One potential problem has been the accuracy of models generated. We performed computed tomography on a cadaveric human patella followed by data conversion using open source software through to selective-laser-sintering of a polyamide model, to allow comparative morphometric measurements (bone v. model) using vernier calipers. Statistical testing was with Student's t-test.

No significant differences in the dimensional measurements could be demonstrated. These data provide us with optimism as to the accuracy of the technology, and the feasibility of using RP cheaply to generate appropriate models for operative rehearsal of intricate orthopaedic procedures.