David Oka // Innovasis
A real-world patient registry powered by AI-based image analysis: The BioBaseTM Registry from Innovasis
Challenge
Collecting and securely storing patient outcomes and medical images from over 50 clinical sites.
Outcome
Collecting meaningful real-world data demonstrating improved patient outcomes and high product quality.
Excerpt
In 2018, Innovasis, a US-based manufacturer of bioactive spinal implants, partnered with RAYLYTIC to set up a multicenter, quality assessment patient registry (BioBase™ Registry1) for their intervertebral body fusion devices.
Challenge: Setting up a real-world patient registry
In 2018, Innovasis celebrated the launch of their new line of bioactive spinal implants.
For the US-based implant manufacturer, this release was a major development in the use of high-performance materials in their interbody fusion devices.
As an outcome-driven company, Innovasis wanted to provide surgeons with a long-term source of actionable real-world-data. An implant and patient registry proved to be a viable option for data collection.
However, getting a large, multicenter registry up and running proved to be a major undertaking.
The primary challenge was the scope of the database. To promote optimal patient outcomes, the registry had to include data from all stages of the treatment process. Therefore, it had to offer sites an efficient way to gather demographic, patient-reported, and imaging data. These kinds of sensitive data added an extra layer of regulatory complexity. The desired solution couldn’t leave any open questions about compliance with HIPAA.
On the front end, the solution had to be integrable into clinical routine as Innovasis was looking to collect data from sites across the United States. Scalability and user-friendliness were therefore non-negotiable.
Finally, the desired patient registry software solution had to offer integrated image analysis capabilities. Innovasis was interested in assessing indicators of device performance, like fusion rates and AP-translational motion. Expertise in orthopedic and spinal imaging was thus critical.
Solution: Scalable, web-based patient registry software
Today, Innovasis uses UNITY as an all-in-one data collection and analysis platform for their registry.
“With UNITY, we are offering surgeons an intuitive way to generate and access meaningful registry data.”
Clinical Affairs at Innovasis
Secure and efficient data collection
With UNITY, Innovasis offers sites in an efficient, secure, and HIPAA-compliant way to gather PRO and imaging data. For patients, completing PRO questionnaires is easy. They can use a tablet at the clinical sites to fill out questionnaires like the ODI, NDI, VAS, or EQ-5D. Questionnaire scoring is automatic, saving clinical staff precious time. When it comes to data storage, patient data always remain secure in an ISO 27001-certified data center.
Uploading medical images is just as efficient. Clinical staff can drag and drop DICOM files into the web-based application. Following the automatic de-identification of the images, UNITY’s AI-based classification systems ensures that only the right images have been uploaded. Color-coded overviews offer clinical staff an intuitive way to identify missing or overdue data.
Independent and precise medical image analysis
Once the images are uploaded, Innovasis uses RAYLYTIC’s imaging core lab services to conduct independent and objective assessments of key radiographic parameters. For example, internal analysis has shown that RoM data may be up to 15 times more precise than manual measurements.2 Furthermore, when it’s time to deliver results, Innovasis has access to reports generated by RAYLYTIC’s team of experts.
Outcomes: Significant and actionable real-world data
In the four years since its launch, Innovasis’ BioBase Registry has been an overwhelming success. Now, the registry consists of more than 2,000 patients from over 50 clinical sites.
The data can then be compiled into quarterly study reports that can be directly distributed to clinical sites, where they can be used to identify and correct missing data points, images, and questionnaires.
“It’s helpful for me to be able to tell a patient that their treatment is rooted in objective data collected from surgeons around the United States.”
A symbiosis of technology, individualized care, and efficient exchange of information, Innovasis’ BioBase registry is achieving exactly what it set out to do. Each enrollment means more informed decisions for existing and future patients alike.
Data from the registry has been the basis for several successful abstract submissions, for example at the Spine Summit 2023 in Miami, Florida. One of which “Radiographic and Patient-Reported Outcomes in a Large Cohort of Patients undergoing ACDF using Hydroxapatitite Infused Interbody Spacers: Two Year Results,” was granted the Todd Albert Scholars Award, an accolade for the top 50 scoring abstracts submitted to the conference.
- https://www.innovasis.com/technology-copy
- Schulze, Martin & Trautwein F, Vordemvenne T, Raschke M, Heuer F (2011): A method to perform spinal motion analysis from functional X-ray images. J Biomech 44(9): 1740-1746.
https://www.youtube.com/watch?v=V6j1FoTNA-s