Clinical Evidence by Therapeutic Area
The results of research studies utilizing Orthofix products and technologies have been published in a variety of forums, including scholarly journals. Some of these works are highlighted below under their respective therapeutic area.
Bone Growth Therapies
With almost 40 years of healing patients, our bone growth therapy devices are the number one prescribed bone growth stimulators in the U.S. These devices provide patients with safe, non-surgical treatment options for promoting spinal fusion and healing nonunion fractures. Using Orthofix’s pulsed electromagnetic field (PEMF) technology, the devices generate a uniform, low-level electrical field that helps activate and augment the body’s natural healing process to enhance bone fusion.
Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion
A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions
Pulsed electromagnetic field stimulation may improve fusion rates in cervical arthrodesis in high-risk populations
Pulsed electromagnetic fields for the treatment of tibial delayed unions and nonunions. A prospective clinical study and review of the literature
Spine fusion for discogenic low back pain: outcomes in patients treated with or without pulsed electromagnetic field stimulation
Three-and 4-level lumbar arthrodesis using adjunctive pulsed electromagnetic field stimulation: a multicenter retrospective evaluation of fusion rates and a review of the literature
Our M6™ artificial discs are the natural choice for helping preserve motion in patients undergoing cervical or lumbar disc replacement. Designed to mimic a patient’s natural vertebral disc, our M6 discs are the only artificial discs that incorporate an artificial nucleus and woven fiber annulus. This design aims to provide the same motion characteristics of a natural disc, including compressive capabilities and a controlled range of motion.
Comparison of in vivo kinematic and radiological parameters of three cervical disc prostheses
Longitudinal assessment of segmental motion of the cervical spine following total disc arthroplasty: a comparative analysis of devices
Comparison of M6-C and Mobi-C cervical total disc replacement for cervical degenerative disc disease in adults
Cervical total disc replacement using a novel compressible prosthesis: Results from a prospective Food and Drug Administration-regulated feasibility study with 24-month follow-up
A Retrospective Review of Radiographic and Clinical Findings from the M6 Cervical Prosthesis
Are Collapsed Cervical Discs Amenable to Total Disc Arthroplasty?: Analysis of Prospective Clinical Data With 2-Year Follow Up
Comparative Study Between M6-C and Mobi-C Cervical Artificial Disc Replacement: Biomechanical Outcomes and Comparison with Normative Data
Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study
Our biologic solutions play an important role in a number of surgical applications, including allografts with viable cells, structural allografts, synthetic bone grafts, and amniotic membranes. By supplying the key elements needed for bone healing coupled with its enhanced handling properties, the Trinity ELITE® and Trinity Evolution™ allografts with viable cells have been implanted in more than 200,000 procedures.