ABSTRACT BOOK SPINALOGIC ® AND OL1000 ™ BONE GROWTH STIMULATION
PRE CLINICAL SCIENCE
THE EFFECT OF LOW FREQUENCY ELECTRICAL FIELDS ON OSTEOGENESIS MCLEOD, KJ; RUBIN, CT SUMMARY: The purpose of this study was to evaluate the effect of low frequency electromagnetic field on bone healing. This study utilized an animal osteopenia model to help determine the osteogenic potential created by these fields. The various fields were applied for 1 hour a day for 56 days. A cross section of the mid-diaphysis of both the functionally isolated and intact contralateral ulna was analyzed. The low frequency (less than 150 Hz) electromagnetic field prevented osteopenia and demonstrated an osteogenic effect that was dependent on frequency. The very-low frequency sinusoidal fields are similar to those produced intrinsically by normal function created the greatest mean change in bone area. Since this frequency range is correlated to normal functional activity, it also verifies that electricity plays a role in normal bone retention. This study provides scientific evidence that the CMF ™ application may prevent bone loss in an osteopenic bone model. In addition, it verifies that the low frequency in the CMF device is all that is needed to stimulate an osteogenic response with only 1 hour of application.
“ VERIFIES THAT THE LOW FREQUENCY IN THE CMF ™ DEVICE IS ALL THAT IS NEEDED TO STIMULATE AN OSTEOGENIC RESPONSE ”
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PRE CLINICAL SCIENCE
EXPOSURE TO LOW FREQUENCY CMF ™ RESULTED IN A SIGNIFICANT INCREASE IN CELLULAR CA+ FLUX FITZSIMMONS RJ, RYABY JT, MAGEE FP, BAYLINK DJ
SUMMARY: The in vitro study investigated the lower amplitude CMF ™ effect on osteoblast-like bone cells (TE-85 and SaOS-2), a common model used to measure electrical stimulation cellular effect. The impact of the CMF signal was determined by measuring Ca uptake into the bone cells, or Ca flux. The authors also examined the differentiation state of the bone cells by examining the alkaline phosphatase (ALP) levels. Both a time and frequency dependent response was noted by the cells to the signal. The Ca uptake increased with increased exposure to the signal for up to 40 minutes. The optimal frequency for uptake was observed to be between 15.3Hz and 16.3Hz. Also, these trends were not dependent on the state of differentiation of the bone cells.
“ SIGNIFICANT INCREASE IN CELLULAR CA+ FLUX ”
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PRE CLINICAL SCIENCE
ROLE OF INSULIN LIKE GROWTH FACTOR II IN MAGNETIC FIELD REGULATION IN BONE FORMATION RYABY JT, FITZSIMMONS RJ, KHIN N, CULLEY P, MAGEE F, WEINSTEIN A, BAYLINK DJ SUMMARY: The authors investigated the biological mechanism by which combined alternating current and direct current magnetic fields (CMF ™ ) help promote bone growth. The study focused on insulin-growth factors (IGF) because of the ability of IGF to stimulate osteoprogenitor cell proliferation, with DNA synthesis service as a marker for cell proliferation. The effect of CMF on IGF-II production and DNA synthesis was measured in both osteoblast-like cell cultures as well as rat fracture callus culture model after 30 minutes of exposure to CMF per day. Samples were collected at 18-24 hours post exposure as well to look at the duration of the effect of the CMF exposure. This cell culture analysis indicates that the potential pathway for the up regulation of bone cell proliferation is due to the increase in synthesis and secretion of IFG-II. The increase in IGF-II was seen at 18-hour post exposure in the cell model. The cellular response was then confirmed in an animal cell culture model for fracture healing. The animal cell culture model showed the effect of CMF on IGF-II varied depending on the state of healing. This up regulation was seen at 24 hours after exposure to CMF.
“ THE EFFECT OF CMF ™ ON IGF-II PRODUCTION WAS MEASURED AFTER 30 MINUTES OF EXPOSURE PER DAY ”
ACCESS THE FULL ABSTRACT AND ARTICLE: HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/ABS/PII/0302459894870160
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PRE CLINICAL SCIENCE
IGF-II RECEPTOR NUMBER IS INCREASED IN TE-85 OSTEOSARCOMA CELLS BY COMBINED MAGNETIC FIELDS FITZSIMMONS RJ, RYABY JT, MAGEE FP, BAYLINK DJ SUMMARY: The authors sought to understand how exposure to the Combined Magnetic Field (CMF ™ ) signal affected insulin like growth factor (IGF II) receptor levels. This was a sham controlled in vitro study looking at the effect of CMF on insulin like growth factor receptor regulation in human osteosarcoma-derived osteoblast-like cells, TE-85. The study showed that a 30-minute treatment with CMF increased the IGF-II receptors in osteoblast-like cells. The effect of the exposure was also frequency dependent with the maximum increase at 15.3Hz. In addition, the exposure to CMF also increased the dissociation constant. The sham had no effect on the cells.
“ 30-MINUTE TREATMENT WITH CMF ™ INCREASED THE IGF-II RECEPTORS ”
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/?TERM=7639117
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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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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 ™ ”
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://PUBMED.NCBI.NLM.NIH.GOV/28134611/
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FRACTURE CLINICAL STUDIES
EFFICACY OF ELECTRICAL STIMULATORS FOR BONE HEALING: A META-ANALYSIS OF SHAM-CONTROLLED RANDOMIZED TRIALS ALEEM I, EVANIEW, N, YASZEMSKI M, EINHORN T, BHANDARI M SUMMARY: The purpose of this study was to conduct a meta-analysis of randomized sham- controlled trials to interrogate the efficacy of electrical stimulation for bone healing. The 15 publications incorporated in the analysis included studies with combined magnetic field (CMF ™ ), pulsed electromagnetic field (PEMF) and capacitive coupling (CC) electrical stimulation technologies. Effectiveness outcomes included pain reduction, clinical assessments and radiographic fusion. This study demonstrated a statistically significant (p = 0.02) reduction in patient reported pain, signifying the first time a meta-analysis on bone growth stimulators, with little to no heterogeneity, identified statistical significance in pain improvement. Results showed that electrical stimulation significantly reduced the rate of nonunion by 35% (p<.01) when compared to the control treatment group (sham device or no treatment). The effect on both nonunion risk and pain reduction was consistent across all indications.
“ EFFECT ON BOTH NONUNION RISK AND PAIN REDUCTION WAS CONSISTENT
ACROSS ALL INDICATIONS ”
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://PUBMED.NCBI.NLM.NIH.GOV/27539550/
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SPINE CLINICAL STUDIES
COMBINED MAGNETIC FIELDS ACCELERATE AND INCREASE SPINE FUSION: A DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY LINOVITZ RJ, PATHRIA M, BERNHARDT M, GREEN D, LAW MD, MCGUIRE RA, MONTESANO PX, RECHTINE G, SALIB RM, RYABY JT, FADEN JS, PONDER R, MUENZ LR, MAGEE FP, GARFIN SA SUMMARY: This investigational, randomized controlled study examines the safety and effectiveness of the DJO ® Spinalogic ® as an adjunct treatment to aid patients that underwent primary lumbar fusion surgery at one or two levels without instrumentation. Patients received autograft alone or in combination with allograft. Overall, 201 patients were available for evaluation, with radiographic fusion determined by panel blinded to treatment group (active vs. sham device) Adjunctive use of the DJO Spinalogic device significantly increased lumbar fusion from 43% to 64% (p=.001) at the 9 months follow up. The generalized estimating equations model indicated successful radiographic spinal fusion and showed a significant acceleration of the healing process (p=0.0024). The study showed that the Spinalogic device can accelerate the healing process. The IDE study supported PMA approval for the Spinalogic indication of primary lumbar fusion at one or two levels. In conclusion, adjuvant use of Spinalogic was statistically beneficial in the overall patient population.
“ THE DJO ® SPINALOGIC ® SIGNIFICANTLY INCREASED LUMBAR FUSION ”
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://PUBMED.NCBI.NLM.NIH.GOV/12131732/
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SPINE CLINICAL STUDIES
COMBINED MAGNETIC FIELDS PROVIDE ROBUST COVERAGE FOR INTERBODY AND POSTEROLATERAL LUMBAR SPINAL
FUSION SITES STIPPICK TW, SHELLER MR
“ SIMULATIONS OF THE MAGNETIC FIELD CONFIRMED COMPLETE AND TARGETED COVERAGE ”
SUMMARY: The purpose of this study was to model the therapeutic field associated with a bone growth stimulator utilizing the DJO ® Spinalogic ® device. Simulations of the magnetic field confirmed complete and targeted coverage of the bone graft volumes for both interbody and posterolateral spinal fusion sites. In addition, the electric field was several orders of magnitude less than any reported study demonstrating a biological effect. Given its clinical effectiveness, a CMF ™ bone growth stimulator must rely on the combined magnetic fields activity, rather than its electric field, for a therapeutic effect.
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://PUBMED.NCBI.NLM.NIH.GOV/26044553/
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SPINE CLINICAL STUDIES
INCREASED SPINAL LUMBAR FUSION WITH COMBINED MAGNETIC FIELD (CMF ™ ) BONE GROWTH STIMULATION ELSABEH R, STEGALL R, ABRAHAMS J (2020) J ORTHOP SURG TECH 2020 3(1):84-91 SUMMARY: The purpose of this study was to evaluate DJO ® Spinalogic ® treatment following lumbar fusion in a retrospective analysis. The study utilized both clinical and radiographic fusion criteria, included data from 11 surgeons and consisted of a heterogenous patient population. The study included 316 patients, with some patients having limited data availability. Patients were followed for a minimum of 6 months. Adjunct CMF ™ treatment was associated with significantly shorter time to fusion of 166 days compared to 244 days for patients did not receive and bone growth stimulation (p = 0.002). In conclusion, treatment with the Spinalogic device following lumbar fusion surgery improved time to fusion compared to patients that received no stimulation.
“ CMF ™ TREATMENT WAS ASSOCIATED WITH SIGNIFICANTLY SHORTER TIME TO FUSION ”
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://SCHOLARS.DIRECT/ARTICLES/ORTHOPEDIC-SURGERY/JOST-3-015.PHP?JID= ORTHOPEDIC-SURGERY
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SPINE CLINICAL STUDIES
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 RAISZADEH R, RAISZADEH K, EATON L, KIM P, KIM C SUMMARY: The study aimed to evaluate DJO ® Spinalogic ® treatment following lumbar fusion in a retrospective analysis. The study utilized radiographic fusion criteria, included data from 4 surgeons and consisted of a heterogenous patient population. The study included 652 patients, with some patients having limited data availability. Patients were followed for a minimum of 6 months. The study observed that 97% of patients treated with CMF ™ (n=343) fused compared to 62% of patients that received no stimulation (n=309) (p < 0.00001). Moreover, exposure to the Spinalogic device was not associated with increased risk of post- operative complication compared to patients that did not receive a bone growth stimulator (29 vs. 22 post-operative complications, respectively).
“ PATIENTS TREATED WITH CMF ™ SHOWED AN INCREASE IN FUSION RATE COMPARED TO PATIENTS THAT RECEIVED NO STIMULATION ”
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://WWW.RESEARCHGATE.NET/PUBLICATION/339817862
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ARTICLES RELATED TO ELECTRICAL BONE STIMULATION
ECONOMIC BURDEN OF ILLNESS AMONG US PATIENTS EXPERIENCING FRACTURE NON-UNION WU N, LEE Y, SEGINA D, BENJAMIN N, BOULANGER L., MURRAY H, WILCOX T SUMMARY: Given the growing prevalence of diabetes and the increased risk of impaired healing for diabetic patients, the costs associated with obtaining successful fracture repair will continue to be substantial for patients and payor alike. As such, the purpose of this study was to explore the resource use and healthcare costs associated with electrical bone growth stimulation (EBGS), low-intensity pulsed ultrasound (LIPUS) and neither (No-stim) in managing fracture non-unions within both diabetic and non-diabetic patients. Medical and pharmacy claims were used to identify both diabetic and non- diabetic subjects who were newly diagnosed with a fracture nonunion. Overall, 11,628 non-union patients were included in the study with a breakdown of 29.5% of the electrical bone growth stimulators (EBGS) group, 12.3% in the low intensity pulsed ultrasound (LIPUS) group and 58.2% in the no stim group. At 1-year post nonunion diagnosis, EBGS treated patients were predicted to have significantly less healthcare associated costs than LIPUS treated patients (mean: $21, 632 vs. $23,964, p<0.01) and the no-stim patients (mean: $21,632 vs. $23,843, p<0.01). Additionally, EBGS treated patients were significantly less likely to receive fracture- related treatments when compared to LIPUS patients (33.6% vs. 43.2%, P < 0.01) and patients that received no stimulation (33.6% vs. 60.3%, P < 0.01). This concluded that, for both diabetic and non-diabetic patients, the use of EBGS resulted in significantly lower healthcare costs for the treatment of non-union.
“ FOR BOTH DIABETIC AND NON-DIABETIC PATIENTS, THE USE OF EBGS RESULTED IN SIGNIFICANTLY LOWER HEALTHCARE COSTS ”
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://WWW.RESEARCHGATE.NET/PUBLICATION/305322572_ECONOMIC_BURDEN_OF_ ILLNESS_AMONG_US_PATIENTS_EXPERIENCING_FRACTURE_NONUNION
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ARTICLES RELATED TO ELECTRICAL BONE STIMULATION
THE EFFECT OF ELECTRICAL STIMULATION THERAPIES ON SPINAL FUSION: A CROSS-DISCIPLINARY SYSTEMATIC REVIEW AND META-ANALYSIS OF THE PRECLINICAL AND CLINICAL DATA COTTRILL E, PENNINGTON Z, AHMED AK, LUBELSKI D, GOODWIN ML, PERDOMO-PANTOJA A, WESTBROEK EM, THEODORE N, WITHAM T, SCIUBBA D SUMMARY: The authors performed meta-analysis on preclinical and clinical data to interrogate the overall effectiveness of electrical stimulation technologies (EST), including direct current stimulation (DCS), capacitive coupling stimulation (CCS) and inductive coupling stimulation (ICS) (e.g. CMF ™ and PEMF). The authors examined 17 preclinical and 16 clinical articles. Clinical studies showed that electrical stimulation significantly increases fusion rates (OR 2.26, p<0.001). Additionally, preclinical studies demonstrated that the fusion rates were higher in electrical stimulation treated animals (OR 4.79, p < 0.001).
“ CLINICAL STUDIES SHOWED THAT ELECTRICAL
STIMULATION SIGNIFICANTLY INCREASES FUSION RATES ”
ACCESS TO THE FULL ABSTRACT AND ARTICLE: HTTPS://PUBMED.NCBI.NLM.NIH.GOV/31593923/
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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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PRESCRIBING INFORMATION
NOTES
DJO ® SPINALOGIC ® INDICATION: SpinaLogic ® is a portable, battery powered, microcontrolled, noninvasive bone growth stimulator indicated as an adjunct electromagnetic treatmentto primary lumbar spinal fusion surgery for one or two levels. 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 SpinaLogic 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). SpinaLogic 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: Do not use the SpinaLogic near products that may have strong magnetic fields, such as audio speakers. The device may not work properly around these products. WARNING! This device is intended only for single patient use. Secondary use can cause serious injury, including infection. Care must be taken when operating this device adjacent to other equipment. Potential electromagnetic or other interference could occur with this or other equipment. Try to minimize this interference by increasing the separation between this device and nearby equipment, and by not using other equipment (i.e.cell phones, MRI, electro surgery, defibrillation, etc.) when you are using this device. The equipment should not be used adjacent to or stacked with other equipment and, if adjacent or stacked use is necessary,the equipment should be observed to verify normal operation in the configuration in which it will be used. Do not use the SpinaLogic while smoking or near heat, fire or flammable gases because the device may be damaged. Do not use the SpinaLogic if there are exposed wires or the device appears damaged. Do not modify or repair this device because you may damage it. Do not put the device or any of its parts in any liquid. Do not drop the device or bend the coils because this may damage it. Device is designed to comply with electromagnetic safety standards. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this equipment on and off. Try to correct the interference using one or more of the following: reorient or relocate the receiving device, Increase the separation between the equipment, contact DJO ® Customer Care. Some people, with very sensitive skin, may experience redness. Generally, this redness is totally harmless and usually disappears after 10 to 20 minutes. However, never start another treatment on the same area if the redness is still visible. If the performance of the device varies in any way from the described operation, call Customer Care. The use of other cables and accessories may affect EMC performance. This device and its accessories must be kept out of the reach of children, Pets, and Pests. Do not use device in contact with open wounds. Contaminationby Patient could be sweat, expired gases, saliva, on the SpinaLogic. Clean the applied part of the coil once a week using soap and a damp cloth. Do not use device while in bath or shower.
CAUTIONS: DO NOT operate this unit in an environment where other devices are being used that intentionally radiates electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
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 SpinaLogic, which has the same treatment signal as the OL1000 ™ and OL1000 SC1, have not indicated any evidence of significant adverse effects.
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T 800.336.6569 D 760.727.1280 F 800.936.6569 2900 Lake Vista Drive I Lewisville, TX 75067 I U.S.A. DJOGlobal.com
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Individual results may vary. This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call DJO ® at 888-624-5450. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.
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