OUTCOME MEASURES FOR EVALUATION OF TREATMENTS FOR OSTEONECROSIS

Introduction: In the evaluation of various treatments that may have an effect on bone, there are certain inherent difficulties in selecting an appropriate outcome measure to determine whether a specific treatment is efficacious. This is particularly true for clinical studies. Methods: Using Pubmed, a service of the U.S. National Library of Medicine that searches MEDLINE and other life science journals for citations of biomedical articles, a review of the current instruments used for outcome measures relating to osteonecrosis and bone blood flow was conducted. Abstracts from previous ARCO meetings were also reviewed. Results: For the treatment of osteonecrosis, most outcome measures have focused on pain relief, surgery or need for surgery, disease progression (advancing stage), and change in lesion size. The first three options may be influenced by investigator bias and knowledge/experience. The last option may also be influenced by the technique used. Imaging techniques continue to gain in sophistication. Gd-enhanced MRI can be used to assess perfusion of the diseased tissue. Doppler ultrasonography has also been used to estimate blood flow noninvasively. Near Infrared Spectroscopy (NIRS) can be used to measure tissue oxygenation. While there has been recent interest in using biomarkers or genetic markers in the diagnosis and analysis of disease progression, more research is needed to determine the sensitivity and specificity of these techniques with respect to osteonecrosis. Conclusion: Although there are a number of tests that can be used to evaluate the effect of a specific treatment on osteonecrosis, the definitive assessment will likely remain whether the disease progresses to the point that major surgery (resurfacing, vascularized fibular grafting, total joint replacement, e.g.) is required to relieve pain and restore function.