FRACTURE CLINICAL STUDIES
USE OF COMBINED MAGNETIC FIELD TREATMENT FOR FRACTURE NON-UNION PHILLIPS M, BAUMHAUER J, SPRAGUE S, ZOLTAN J
SUMMARY: A post-market registry was established to examine the effectiveness of treating non-union fractures with the Combined Magnetic Field (CMF ™ ) DJO ® OL1000 ™ bone stimulation device over a 4-year period. All clinically identified non-unions (without defining parameters) were included as patients were treated for 30 minutes per day for 270 days. All fracture types as well as all times since injury were included in the registry. Healing rate and time were identified for all subjects enrolled. 2370 subjects were followed until their fractures were healed as determined by: no motion was demonstrated at the fracture site, three or more cortices were seen bridging the fracture gap by radiographic assessment, and there was no pain associated with the fracture site. Over 15 different fracture types were included in the registry and treatments were initiated between 2 and 9 months or more that 9 months after injury. This provided for a broad subject population. Overall, there was a 75% healing rate and a time-to- heal of 4.9 months +/– 1.0 months for the 2370 patients. It was demonstrated that time to treatment after injury had an impact on the healing rate. Those treated 2 months after injury demonstrated considerably higher healing rates than that in patients treated 9 month or more after injury (82.6% vs. 68.7%). In addition, those subjects treated earlier after injury had a shorter time-to-heal. These results indicate the potential benefit of early intervention using CMF treatment following injury, because delayed treatment initiation may result in a poorer response to treatment. The results of this study further demonstrate the effectiveness of the DJO OL1000 device to aid the treatment of a broad range of fracture non-unions by increasing the healing rate and decreasing healing time.
“ RESULTS OF THIS STUDY FURTHER DEMONSTRATE THE EFFECTIVENESS OF THE DJO ® OL1000 ™ ”
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