Automated image data analysis for efficient study management

AI-based software for clinical trials in orthopedics

AI-based, validated and highly precise

Image data analysis for clinical trials in orthopedics

In order to sustainably improve both conservative and surgical treatment of musculoskeletal diseases and injuries, we have developed various algorithms for analyzing medical image data.

The first algorithm set frees clinicians and surgeons from time-consuming routine tasks, such as the evaluation of sagittal balance parameters or alignment angles of the lower limbs. These algorithms are at least as precise as human measurements, while autonomously analyzing large data sets, e.g. in nationwide registries.

The second group of algorithms enables objective, reliable and highly accurate analysis of X-ray parameters for quantitative and qualitative assessment of implant performance, e.g. in clinical trials, post-market surveillance studies, IDE, registries or research.

The superior precision of image analysis combined with our UNITY platform, which streamlines study management processes, provide you with a significant reduction in workload and study-related costs.

Do you have questions about UNITY or AI-based image data analysis?

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High-precision image data analysis thanks to artificial intelligence

The various AI-based modules for image data analysis integrated in UNITY enable objective, reliable and highly precise analysis of radiological parameters for quantitative and qualitative assessment of the performance promise of implants.

Due to the precision we achieve, meaningful conclusions can be drawn even from smaller patient cohorts, significantly reducing study-relevant costs.

In addition, the range of motion (ROM) measurements we perform currently achieve 15 times higher accuracy compared to manual measurements by experienced physicians (Schulze et al., J Biomech, 2011).

Variety of morphological and geometrical parameters

  • Range of Motion
  • Disc Height
  • Sagittal Balance (Pelvic Incidence, Sacral Slope, Pelvic Tilt, etc.)
  • Fusion
  • Loss of Correction
  • Center of Rotation
  • Implant Migration
  • Segmental Instability
  • Prosthesis wear (with accuracies in the µm range)

UNITY ─ More than an EDC system

In addition to the image analysis modules, the UNITY platform also includes a comprehensive EDC (Electronic Data Capture) system.

The combined acquisition and analysis of questionnaires (PROMs, PREMs, CRFs) and imaging endpoints offers numerous advantages for clinical trials in orthopedics and enables deeper insights.

Excerpt of UNITYs functional scope, tailored to orthopedic clinical trials:

  • cross-form validation and risk-based monitoring

  • integrated portfolio of many common questionnaires

  • immediate input validation and automatic evaluation

  • real-time reporting and graphical visualization

  • configurable alarms and e-mail notifications

  • integrated, browser-based data anonymization and transmission

  • automatic image selection and assignment to patient ID

  • study-specific creation of admission instructions, X-ray and data exchange protocols

  • and much more

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High precision image analysis

Reliable analysis of over 100 radiological parameters: sagittal balance, loss of correction, disc height, segmental instability and prosthesis wear.

Powerful data analysis

Extensive data analysis and data export functions with reporting for a quick overall view.

Quality control and assurance

Real-time validation and edit checks. Mid-study changes for protocol adjustments in an ongoing study.

How RAYLYTIC customers profit from our solutions:

As we bring forward more accurate tools for implant placement, we are in need of better methods to assess postoperative alignment and accuracy to planned placement. It seems you have not only filled that need, but also automated the process of acquiring accurate information.

RUSSELL SCHENCK

Director Clinical Strategy at Zimmer Biomet

The UNITY platform is easy to use and the collection of PROMs/CRFs is robust in daily use. The automatic anonymization of the uploaded image data and their statistical analysis are also extremely helpful.

PROF. MICHAEL PUTZIER

Chief Senior Physician at the Center for Musculoskeletal Surgery/Charité Berlin

UNITY facilitates getting patient data and outcome measurements to a higher level. The system is easy to use, the image upload is smooth and complete data analysis is provided quickly and thoroughly, including discussions and advice for improvement.

DR. NANCY LAMERIGTS

Former VP of Research and Marketing at Emerging Implant Technologies

The RAYLYTIC team is extremely competent, diligent and fun to work with. They solve problems and offer support wherever it is needed to get a project up and running. We have already set up multiple studies with RAYLYTIC and are also cooperating on several other projects.

DR. ANDREA WEILER

Director Medical Scientific Affairs at Aesculap/B. Braun

We have built databases for two retrospective studies including image analyses with RAYLYTIC. They helped with designing the eCRF, implemented and trained us on how to navigate the database, provided necessary documents and went above and beyond to help us achieve our goals. Working with RAYLYTIC is fantastic. The team is highly professional and extremely knowledgeable on how to run clinical retrospective studies.

DR. LAMIA BOSLI

Manager Clinical Data Management at RQMIS

RAYLYTIC has created a product that includes all the elements I need for my research, with the highest quality and integrity. In addition, the best part of this product is actually the customer service. I cannot stress enough how impeccable the entire team at RAYLYTIC is, which ultimately makes this product even better.

LINDSAY OROSZ

Senior Manager Clinical Studies at Virginia Spine Institute

The sites and CROs involved in the trials are so relieved to finally have a platform that automates redundant tasks and ensures highest quality data with little extra effort. Our CROs and principal investigators have been extremely impressed with the quality of data coming out of sites and their interactions with RAYLYTIC.

ANDY MURILLO

Spinal Stabilization Technologies

With the use of UNITY, the basis was laid for not having to maintain or introduce an unlimited number of individual solutions for the processing of PROMs and PREMs. This relieves IT managers in the long term.

DANIEL WUNDERLI

ICT-Project Manager at KSW

With UNITY, we are offering surgeons an intuitive way to generate and access meaningful registry data.

DAVID OKA

VP Business Development and Compliance at Innovasis

Electronic Patient-Reported Outcomes (ePRO) and Case Report Forms (eCRF)

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UNITY Research: Powerful analysis and controlling tools to conduct clinical studies efficiently.