FRACTURE CLINICAL STUDIES
THE USE OF COMBINED MAGNETIC FIELD TREATMENT FOR FRACTURE NON UNIONS: A PROSPECTIVE OBSERVATIONAL STUDY PHILLIPS M, ZOLTAN J, PETRISOR BA, SPRAGUE S, BAUMHAUER SUMMARY: The purpose of this study was to evaluate the safety and effectiveness of the combined magnetic field (CMF ™ ) bone growth stimulator device the DJO ® OL1000 ™ to help treat non-union fractures. 116 non-union fractures in 112 patients were treated with the OL1000 device and prospectively followed at 17 sites. Non-unions were defined as 9 months post injury with at least 3 months with no change in healing. A total of 11 different bones were represented (excluding vertebrae and flat bones), with all patients considered skeletally mature. Subjects were treated for 9 months and followed for an additional 3 months post treatment. After 9 months of treatment with the OL1000 device the non-unions demonstrated significant improvement with respect to cortical bridging as well as pain at rest, stress at the fracture site and on weight bearing. These improvements continued for the 3 months of follow up after treatment with OL1000 was complete. In addition, no adverse events related to the use of the devices were noted at all through the course of the study. 73% compliance was noted in all subjects, including those that were removed from the study for all reasons. 61.9% of all non-unions and 78.1% of tibial non-unions went on to heal with treatment with the DJO OL1000 device. All non-unions determined to be healed at the end of the study remained healed at the two-year post-treatment follow-up. DJO OL1000 was shown to be a safe and effective non-invasive treatment to aid fracture non-unions and helps reduce the potential of a subject from having additional surgery to treat non-unions.
“ DJO ® OL1000 ™ IS SHOWN TO BE A SAFE AND EFFECTIVE NON INVASIVE TREATMENT TO AID FRACTURE NON-UNIONS ”
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://PUBMED.NCBI.NLM.NIH.GOV/28134609/
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