Prospective Study of Bone Pathologies Resulting from Acute or Chronic Injury Treated with IntraOsseous BioPlasty® (IOBP®)

The purpose of the study is to determine the continued clinical efficacy and safety of IOBP® in the treatment of SBP and to assess the ability of IOBP® to heal SBP. 

The primary outcome measure is adverse event evaluation to determine whether IOBP® can prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee. 

Secondary objective: To evaluate if IOBP® will improve clinical and patient reported outcomes for pain and function

Outcome Measures: The primary outcome will be to determine whether IOBP® can prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee. Adverse events will be collected for the outcome measure. 

Secondary outcome measures will be assessed through validated outcomes scoring systems, imaging and adverse event reporting. The scoring systems will include the Visual Analog Pain Scale (VAS), International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) and Knee injury and Osteoarthritis Outcome Score (KOOS). MRIs and X-rays will be assessed. 

Investigator – Adam Anz, MD