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Clinical Trial Summary

The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP).


Clinical Trial Description

The study will be a prospective, multicenter, clinical study, enrolling both male and female patients. Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. IRB approval will be obtained by each participating institution. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05314608
Study type Observational
Source Arthrex, Inc.
Contact Justin W Moss, DHSc
Phone 770 584 4972
Email justin.moss@arthrex.com
Status Recruiting
Phase
Start date November 17, 2021
Completion date May 17, 2027