At the end of April 2019, the network of European HTA agencies, EUnetHTA, published the “Custom-made or customizable 3D printed implants and cutting guides versus non-3D printed standard implants and cutting guides for improving outcome in patients undergoing knee, maxillofacial, or cranial surgery.”
As MTRC reported in December 2018, this project is authored by the Danish Social & Health Services and Labour Market (DEFACTUM). The co-author is the Basque Office for Health Technology Assessment (OSTEBA), with four other HTA institutions from all over Europe (Belgium, Croatia, Hungary, and Austria) being dedicated reviewers.
The HTA Core Model Application for Rapid Relative Effectiveness Assessments (REA, v 4.2) was followed for the selection of assessment elements. Manufacturers also provided non-confidential evidence with a focus on the technical characteristics and current use of the technology.
The authors stated that the scope of this assessment is 3D printed custom-made or customizable implants and cutting guides used in adult patients (>18 years) undergoing knee, maxillofacial, or cranial surgery. Comparators of interest are standard non-3D printed implants or cutting guides.
The authors performed a systematic literature search (systematic reviews published April 2013-2018 and primary studies published 2008-2018). The quality of the included reviews was assessed using the Risk of Bias in Systematic Reviews (ROBIS) tool. The Cochrane risk-of-bias (RoB2) tool was used to evaluate the quality in the included RCTs. Risk of bias in cohort and case-control studies was assessed using the Scottish Intercollegiate Guidelines Network (SIGN) methodology checklists. The quality of the body of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE). Eventually, thirteen (13) studies were included, six (6) of which were included in the quantitative meta-analysis.
Effectiveness results
There was very low or low-quality evidence showing that 3D surgery using 3D printed implants and cutting guides in total knee arthroplasty (TKA) compared with standard instrumentation was more precise, as demonstrated through outcomes such as malalignment (hip-knee-ankle angle, coronal femoral alignment, and coronal tibial alignment) or absolute deviation. There were no other clinical relevant or significant results or outcomes in favor of 3D print technology or conventional surgery. Consequently, the authors state that 3D surgery requires further evaluation.
Safety results
The authors found no overall difference in complications between the technologies in TKA, mandibular reconstruction, and cranioplasty. There was a difference in ischaemic time in mandibular reconstruction, with a decrease in ischaemic time in the group using individual 3D printed surgical guides compared to the standard reconstruction group. The data in these studies described only short-term outcomes such as infection, venous thromboembolism, haemarthrosis, ischemia, and operating time.
Organizational impact
Organizational changes are inevitable if 3D printed implants and surgical guides are implemented as a supplement to or as a replacement for standard implants and surgical guides. These changes will mainly consist of workflow changes in the hospital department and competency changes for personnel. The impact of these changes will depend on the organizational scenario implemented.
See the full news (final report, manufacturers’ and external experts’ comments, project plan) in English here.
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