Radio Stereometric Analysis

Literature Pages

Markers suitable for RSA or Radio Stereometric Analysis

RSA stands for radiostereometric analysis describes an advanced method taking x-rays from different directions at the same time, 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 radiostereometric analysis (RSA) x-rays images obtained from the patient  allow surgeons to make precise measurements on how the body and the implant are interacting and it is possible to gain a very precise evaluation of the prosthesis migration down to approximately 0.1 mm. In case of the of a total hip implant the data may tell if the current wear between the head and the cup has caused a significant amount of lost material and a replacement is required. Due the large numbers of hips surgeries, wear between hips and cups has been the main content for many examinations within the RSA studies of a potential problem group. As tantalum markers are radio-opaque and requires only a low x-ray dose for examination.

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 information more than 150 references to relevant articles 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 in also support you with documentation relevant for your technical file in case your organisation are preparing for placing a CE-marked product on the market.