At Orthofix, we are committed to developing new products in all areas of our business, and we do this through Investigational Device Exemption studies (IDEs), as well as post-approval and post-market studies. IDE studies are used to bring new products or existing products with new indications to market. Post-market studies allow us to examine the effectiveness of our products in a real-world setting. In a post-market study, physicians follow their patients for a period time so that the effectiveness of a device or product can be further evaluated by Orthofix.
The purpose of this study is to determine if using a pulsed electromagnetic field (PEMF) device — in addition to having the tear repaired surgically — reduces the rate of tendons being torn again and improves patient outcomes.
IDE Study
In February 2019, we were given premarket approval (PMA approval) for the M6-C™ artificial cervical disc and are currently conducting the post-approval study for the M6-C disc.
Clinical Study
The purpose of this study is to examine fusion rates following cervical fusion surgery in patients wearing the CervicalStim™ device. Device compliance will be correlated with fusion success. Device compliance will also be correlated with fusion success.
Clinical Study
The purpose of this study is to examine fusion rates following lumbar fusion surgery in patients wearing the SpinalStim™ device. Device compliance will also be correlated with fusion success.
Clinical Study
The purpose of this study is to examine fusion rates following lumbar fusion surgery in patients in which the Trinity ELITE® allograft was used in either an interbody cage or the posterolateral gutters. Fusion will be determined using CT scans and conventional imaging using independent radiographic reviewers.
Clinical Study