Fixation of custom 3D metal printed pelvic implants, A Clinical RSA study

A 3D metal-printed implant will be anchored to the pelvic bone by the
orthopedic surgeon. The specific design in combination with screws ensure that
the implant is immediately attached to the pelvic bone. It is also expected
that good long-term anchoring will take place, partly due to the ingrowth of
the bone into the implant. Treatment with a 3D metal printed pelvic implant has
developed rapidly in recent years due to technological advances. It is a
promising technique and the use of these implants has been used more and more
globally in the last 5 years. There is sufficient evidence for good results
from this method in the short term (2 to 5 years).

It is important to know what the long-term results will be (10 to 20 years).
One of the main reasons why an implant continues to work well in the long term
is its anchoring to the pelvic bone. To measure the anchoring of a prosthesis
to the bone, use can be made of the research technique called X-ray
Stereophotogrammetric Analysis (RSA). With RSA, special x-rays of the pelvis
are taken at specific times in the months and years after the operation. With
this, the difference in the position of the implant with respect to the pelvic
bone can be measured very accurately. RSA is a widely used research technique
worldwide and is seen as the gold standard for the measurement of anchors of
joint prostheses. Based on the RSA results of the first two years after
surgery, it is often possible to predict whether the implant will remain well
anchored to the bone in the long term. This RSA technique has never been used
with this type of implant, which is the main goal of this study.

Prospective observational cohort

implnatation of 3d printed metal implant and RSA markers around the implant

For this study, the patient does not have to come to the hospital more often
than to the normal follow-up with the surgeon. The visits are somewhat more
frequent in the first year. After this, these moments decrease. At every visit,
in addition to the normal checks that the orthopedic surgeon does, an extra RSA
X-ray will be made. The patient will also be asked to complete a number of
questionnaires (PROMS). In addition, the researchers collect some medical data,
which relate to the treatment. No side effects, risks, complications or other
adverse effects or inconveniences are to be expected in the context of this
study.