Clinical Studies
Literature shows very few clinical SIJ fusion trials until 2012. There seems to be a lack of consensus within the medical community about the pain generator and appropriate therapies – particularly for preoperated and chronic pain patients. Therefore a standardized study protocol has not yet be developed.
Randomized comparative studies of surgical methods are required. Premise: availability of a reference procedure. Medical device industry initiated some single-arm studies (single- or multicentered), and also some randomized studies have been started using non surgical therapies as a 2nd arm.
Discussion: Proposed study design
Above proposals can be discussed in the conception of clinical trials for sij fusion. Supplemental concepts for non surgical comparative studies must be worked out as well.