Hui Jenny Chen, MD and Michelle Gabriel, MS, MBA
(This blog is adapted from our A Roadmap from Idea to Implementation: 3D Printing for Pre-Surgical Application: Operational Management for 3D Printing in Surgery)
Clinical trial design should be an important part of the strategic consideration because more clinical evidence, especially in terms of clinical efficacy and outcomes, will strengthen arguments for reimbursement. According to ClinicalTrials.gov , a registry for clinical trials maintained by NIH and NML, “a clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes.”
Good clinical trials serve several major purposes such as:
a) Informing consumers about the values of this technology.
b) Preparing data for new CPT coding and other reimbursement strategies from payers.
c) Inspiring creative innovations.
Data on clinical outcomes is crucial. In recently published studies, researchers have been focusing on the following outcome metrics: operating room time, hospital stay, surgical complication, and post-surgical accuracy. Non-quantitative outcome metrics include patient/family satisfaction.
There are two public clinical trials registered on clinicaltrials.gov for pre-surgical applications (Link). The first one is a recently completed randomized controlled clinical trial (Link) from Cleveland Clinic, “Acetabular Shell Positioning Using Patient Specific Instruments” which has shown a statistically significant increase in anteversion accuracy when using a 3D printed surgical guide over traditional planning methods in total hip arthroplasty (THA) . A limitation to the study is a modest sample size of 36 patients although it is larger than most recently published studies. A second drawback of the study is the lack of information on other clinical outcomes, including hardware loosening and failure as a result of inaccurate placement. This latter issue will require long-term, continuous follow up with the patients.
The second study is currently enrolling (Link). It is focusing on 3D printed patient-specific simulations for endovascular aneurysm repair as a pre-surgical training tool.