Radio Stereometric Analysis

Literature Pages

X-ray Markers suitable for RSA or Radio Stereometric Analysis and insertion into e.g. PEEK materials
  1. RSA (radiostereometric analysis) describes an advanced method of taking x-rays from different directions at the same time, thus creating a “stereo” image.  In order to carry out RSA measurements, the prostheses (e.g. the hip femoral implants) are marked with spherical tantalum markers which can be recognized by computer software algorithms.  In addition to marking the medical device, the RSA markers are placed in the bone near the prosthesis.  The RSA x-ray images obtained from the patients allow surgeons to make precise measurements on how the body and the implant are interacting with each other, and it is possible to gain a very precise evaluation of prosthesis migration, down to approximately 0.1 mm.  In the case of a full hip implant, the data may tell if the wear between the head and the cup has caused a significant amount of material loss and a replacement is required. Due to the large volume of hip surgeries being performed, the wear between hips and cups has been a major cause for many examinations within the RSA studies of a potential problem group.  Tantalum markers are radio-opaque and requires only a low x-ray dose for examination, making them ideally suited for this purpose.

Spherical tantalum markers have been used for more than 30 years without any severe events reported. X-medics’ tantalum RSA markers have today been used in clinical trials on several thousand patients.

Below on the page you can find more than 150 references to relevant articles on this procedure, helping you to plan and conduct your RSA study.

Literature on Tantalum RSA

Available RSA Markers

X-medics offers tantalum RSA marker beads suitable for permanent implantation inside the human body during clinical trials. The products are not CE-marked nor FDA Registered and are delivered non-sterile.

X-medics is however participating in a number of clinical studies and we plan to offer a CE-marked product at a later stage.  We may also be able to help you with documentation relevant for your technical file in the event that your organization is preparing for placing a CE-marked product on the market.

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