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Standards We Test

ISO 16087

Implants for surgery — Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants

Service Overview

Many new joint replacement components that receive FDA and Health Canada approval are introduced to the arthroplasty market with limited evidence of survivorship or improvement over previous designs. Radiostereometric Analysis (RSA) can be implemented to serve as a medical device tracking technology for total joint replacements in order to gain insight regarding their long-term performance.

Our experienced surgical and engineering teams are able to evaluate in vivo hip, knee, and shoulder replacement stability. In addition, we are able to perform a variety of in vivo bearing material characteristic assessments using RSA.

Additional Information

What equipment do you use for testing?

The CJRG uses state-of-the-art Marker-Based and Model-Based RSA technology (Halifax Biomedical). The carbon-fibre uniplanar RSA frame is able to detect up to 0.1mm of motion in the hip and shoulder. Our engineers have extensive experience with pre-trial phantoms and proof-of-concept testing, and are trained for radiographic acquisition and analysis.

Why is this type of testing important?

RSA is a technique that employs digital X-Ray technology to acquire the 3-dimensional coordinates of an implanted medical device. This technique has been used to evaluate implants for over 40 years, and has been shown to accurately predict failures in total hip and knee replacements through early detection of micromotion. RSA has proven to be an excellent tool for in vivomeasurement of device fixation and bearing wear. It is a rapid, time-effective technique that generates robust data in as little as two years.

How do you recruit patients to participate in clinical studies?

We work closely with the Concordia Joint Replacement Group (CJRG) at the Concordia Hip & Knee Institute in Winnipeg, Manitoba, Canada on medical device evaluation and clinical trials. The CJRG is an academic, high volume arthroplasty group specializing in primary and revision total joint replacement surgery.

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