PRESCRIBING INFORMATION
REFERENCES
DJO ® OL1000 ™ INDICATION: Noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. CONTRAINDICATIONS: Use of this device is contraindicated in individuals having a synovial pseudarthrosis. Demand-type pacemaker or implantable cardiovertor defibrillator (ICD) operation may be adversely affected by exposure to magnetic fields. Physicians should not prescribe OL1000 ™ for applications that may place the treatment transducers in close proximity to the pacemaker. Further screening by the attending cardiologist is recommended (such as with an electrocardiogram). OL1000 should not be used in the presence of external or internal fixation devices that are constructed from magnetic materials. (NOTE: Almost all fracture fixation devices implanted today are made from non-magnetic materials.) WARNINGS: The safety and effectiveness of the use of this device on individuals lacking skeletal maturity have not been established. Animal studies conducted to date do not suggest any long-term significant adverse effects from use of this device. However, long term effects in humans are unknown. Teratological studies have not been performed with this device. The safety of use of this device during pregnancy or nursing in humans has not been established. PRECAUTIONS: Weight bearing is not advised in the presence of extreme motion at the nonunion site. In the presence of a malaligned nonunion, careful consideration of the use of this device must be undertaken on an individual basis, as treatment with this device is not intended to alter or affect the degree of malalignment. The safety and effectiveness of the use of this device on individuals with nonunion secondary to, or in conjunction with, a pathological condition have not been established. This device should not be used if there are mental or physical conditions that preclude patient compliance with the physician and device instructions. When conditions of atrophy are present or when fractures have remained unhealed for long periods of time, there may be less successful results. ADVERSE EFFECTS: No known significant adverse effects have resulted from the use of this device. Clinical studies, animal studies, and tissue culture experiments conducted with the OL1000, which has the same treatment signal as the OL1000 SC1, have not indicated any evidence of significant adverse effects. CAUTION: Federal law (U.S.A. and Canada) restricts this device to sale, distribution or use by or on the order of a physician. OL1000 Postmarket Patient Registry Data OL1000 Bone Growth stimulator Post market Patient Registry Data: As of June 30, 1998, the CMF ™ OL1000 had been applied to 5300 patients with physician diagnosed nonunion with varying times from injury, two months or greater. Patient registry data was collected from December 1994 to December 1998. At the time of database closure, we expected follow-up on 4100 patients and received follow-up on 2370 patients (57.8%). Physician diagnosed healing determined patient outcome in the patient registry. All patients were treated for 30 minutes per day, and devices were programmed to provide a maximum of 270 days of treatment. The results of these 2370 patients are presented above. ** The success rate of 51/84 patients in pre-marketing clinical data was 60.7% and was maintained at 2 years post treatment with 90% follow-up of all healed fractures. In the pre-marketing clinical data was 60.7% and was maintained at 2 years post treatment with 90% follow-up of all healed fractures. In the pre-market study non-union was considered to be established when a minimum of nine months had elapsed since injury and the fracture site showed no visibly progressive sighs of healing for a minimum of 3 months. Patient success was defined as three out of four corticies bridged on radiographic and no pain or motion at the fracture site. For additional detailed information on pre-market prospective study, contact DJO ® .
1. Mcleod, Kenneth J., and C. T. Rubin. “The effect of low-frequency electrical fields on osteogenesis.” J Bone Joint Surg Am 74.6 (1992): 920-9.
2. Fitzsimmons, R. J., et al. “Combined Magnetic Fields increased net calcium flux in bone cells.” Calcified tissue international 55.5 (1994): 376-380.
3. Ryaby, James T., et al. “The role of insulin-like growth factor II in magnetic field regulation of bone formation.” Bioelectrochemistry and Bioenergetics 35.1-2 (1994): 87-91.
4. Fitzsimmons, Robert J., et al. “IGF‐II receptor number is increased in TE‐85 osteosarcoma cells by combined magnetic fields.” Journal of Bone and Mineral Research 10.5 (1995): 812-819.
5. Phillips, Mark, et al. “The Use of Combined Magnetic Field Treatment for Fracture Nonunion: A Prospective Observational Study.” Journal of Long-Term Effects of Medical Implants 26.3 (2016).
6. Phillips, Mark, et al. “Use of Combined Magnetic Field Treatment for Fracture Nonunion.” Journal of Long-Term Effects of Medical Implants 26.3 (2016).
7. Bhandari, M., et al. “Efficacy of Electrical Stimulators For Bone Healing: A Meta-Analysis Of Randomized Sham-Controlled Trials.” Orthopaedic Proceedings. Vol. 98. No. SUPP_20. The British Editorial Society of Bone & Joint Surgery, 2016.
8. Linovitz, Raymond J., et al. “Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo-controlled study.” Spine 27.13 (2002): 1383-1388.
9. Stippick, Timothy Wade, and Michael Richard Sheller. “Combined magnetic fields provide robust coverage for interbody and posterolateral lumbar spinal fusion sites.” Medical & Biological Engineering & Computing 54.1 (2016): 113-122.
10. Elsabeh, R., R. Stegall, and J. Abrahams. “Increased Spinal Lumbar Fusion with Combined Magnetic Field (CMF) Bone Growth Stimulation.” J Orthop Surg Tech 3.1 (2020): 84-91.
11. Raiszadeh, Ramin, et al. “Effectiveness of combined magnetic field bone growth stimulation on lumbar spinal fusion outcomes: a single center retrospective analysis comparing combined magnetic field to no-stimulation.” International Journal of Research in Orthopaedics 6.3 (2020): 1.
12. Wu, Ning, et al. “Economic burden of illness among US patients experiencing fracture nonunion.” Orthopedic Research and Reviews 5 (2013): 21.
13. Cottrill, Ethan, et al. “The effect of electrical stimulation therapies on spinal fusion: a cross- disciplinary systematic review and meta-analysis of the preclinical and clinical data.” Journal of Neurosurgery: Spine 32.1 (2019): 106-126.
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