3D technology is increasingly being used, especially in orthopaedic surgery and
traumatology as it allows to define specific objects and to understand structures and
system dynamics. From patient TC images and using a biomedical engineering software, an
exact 3D virtual model of the anatomical region can be created, enabling visualization,
planning and simulation of the entire surgery. Besides, this software allows to design
custom-made surgical guides (that precisely define cutting zones and screw positioning)
as well as personalized implants that perfectly fit the patient's anatomy. After that,
Patient-Specific Instrumentation can be manufactured using 3D printers and biocompatible
materials and they can be sterilized to be used in the operating room.
While personalized surgical guides increase surgical precision and surgeon satisfaction,
personalized implants have shown to generate better clinical outcomes, both short and
long term. Despite of the benefits that 3D technology can generate in the medical field,
most surgeons still opt for conventional 2D planning techniques, free-hand surgeries and
generic implants use. This results in a non-standardized and variable procedure that
heavily depends on the surgeon´s experience and in many cases, the obtained results
deviate from the initial goals. Scientific evidence shows that a lack of precision is
strictly related to clinical complications. Poor alignment of the implants can cause
damage to internal structures, increases chances of dislocations, fractures and
osteolysis as well as reduces the prosthetic component lifespan. That translates into
patient suffering from chronic pain, reduced functionality and an increased number of
reinterventions.
Regardless of the potential and several applications of 3D technology, there´s still a
lack of clinical evidence, and the economic impact is still unknown. This methodology is
increasingly being used as a routine medical process in many institutions but still
raises concerns regarding costs, specially when considering its use in the public health
system. Although digital surgery has a wide variety of associated expenses such as
hardware and software cost, equipment maintenance and 3D-specialised engineers, the cost
of 3D technology has significantly decreased in the past few years and it can potentially
generate economic benefits compared to the standard methodology due to the optimization
of the surgical process; shorter surgeries, reduced number of unnecessary sterilized
materials, reduced number of fluoroscopies during surgery and less medical complications
and revisions.
Thus, a large-scale study is still needed to demonstrate: 1) clinical benefits that 3D
technology can generate compared to conventional surgery and 2) thoroughly analyse its
economic impact to determine if it's a cost-effective methodology. For this reason, a
multi-centre, randomized and prospective study is proposed to evaluate digital surgery's
clinical results and to perform a cost-effectiveness analysis in order to obtain enough
scientific evidence to be able to escalate the use of 3D technology in all public health
institutions.
This clinical trial is a pragmatic study that will evaluate the efficacy and
effectiveness of 3D technology in 3 different surgical procedures; distal radius
osteotomy, acetabular arthroplasty and spinal arthrodesis.
