National Medical Policy

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1 National Medical Policy Subject: Bone Growth Stimulators, Electrical and Ultrasonic Policy Number: NMP194 Effective Date*: January 2005 Updated: May 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Osteogenic Stimulators (150.2): National Coverage Manual Citation x Local Coverage Determination (LCD)* Osteogenesis Stimulators: X Article (Local)* Osteogenisis Stimulators: X Other MLN Matters. Number: MM8304. mplementation Date: July 1, Detailed Written Orders and Face-to-Face Encounters. None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the Bone Growth Stimulators, Electrical and Ultrasonic May 15 1

2 search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement: Health Net, Inc. considers bone growth stimulators medically necessary according to the following: Non-invasive Electrical Bone Growth Stimulators The noninvasive electrical bone growth stimulator (EBGS) device is considered medically necessary in patients 18 years of age or older or demonstrated proof of skeletal maturity for any the following: 1. Nonunion 1 of long bone 2 fractures; or 2. A repeat fusion due to a failed spinal fusion, defined as a spinal fusion which has not healed at a minimum of six (6) months after the original surgery, as evidenced by serial x-rays over a course of three (3) months; or 3. Congenital pseudarthroses 3 of the tibia, fibula, femur, humerus, ulna, radius, clavicle, phalanges, metatarsals or metacarpals where there is no evidence of progression of healing for three or more months despite appropriate fracture care; or 4. Fresh, closed, posteriorly displaced distal radius (Colles') fracture; or 5. Acute, closed or Grade I open diaphyseal tibial fractures after closed reduction or surgery and immobilization; or 6. Delayed unions of fractures or failed arthrodesis at high risk sites (i.e., open or segmental tibial fractures, carpal navicular fractures), or 7. As an adjunct to lumbar spinal fusion surgery for patients at high risk of pseudarthrosis due to any of the following: Previously failed spinal fusion at the same site; or Previous disc surgery; or Gross instability; or Patients undergoing multiple level fusion (a multiple level fusion involves 3 or more vertebrae, e.g., L3-L5, L4-S1; or Grade II or worse spondylolisthesis (The ratio of amount of slippage to vertebral-body width is expressed as a grade or percentage. Grade 1 is a ratio of 0-25%, grade 2 is 25-50%, grade 3 is 50-75%, and grade 4 is %); or Degenerative osteoarthritis; or Infection; or Bone Growth Stimulators, Electrical and Ultrasonic May 15 2

3 Body mass index (BMI) of > 35; or Current smoking habit; or Diabetes; or Alcoholism; or Renal disease (i.e., creatinine greater than 3); or Poor nutrition, particularly protein deficiency. Footnotes: 1. Nonunion is considered to exist when serial radiographs, including a minimum of two sets of radiographs, each including multiple views of the fracture site, have confirmed that the fracture site shows no visibly progressive signs of healing for three or more months prior to starting treatment with the EBGS. Radiographs should be separated by a minimum of 90 days. 2. Long bones include but are not limited to the humerus, femur, radius, ulna, tibia, fibula, clavicle, fifth metatarsal (when significant pain is present), carpal and/or tarsal bones. 3. Pseudarthrosis is a pathologic entity characterized by deossification of a weightbearing long bone, followed by bending and pathologic fracture, with inability to form normal bony callus, leading to existence of the "false joint" that gives the condition its name. Invasive (Implantable) Electrical Bone Growth Stimulators Health Net, Inc. considers the invasive stimulator device medically necessary in patients 18 years of age or older or demonstrated proof of skeletal maturity for any the following: 1. Nonunion of long bone fractures, i.e., the fracture site shows no visibly progressive signs of healing as determined by serial x-rays; or 2. As an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis due to previously failed spinal fusion at the same site or for those undergoing multiple level fusion. A multiple level fusion involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc.). Ultrasound Bone Growth Stimulators I. Health Net, Inc. considers non-invasive low intensity ultrasound bone growth stimulators 1 medically necessary in skeletally mature adults 2 when used as an adjunct to conventional management (including but not limited to closed reduction, cast immobilization) for the treatment of fresh fractures 3, when there is high risk for delayed fracture healing or nonunion for any of the following high risk locations: Tibial diaphysis (i.e., fresh, closed or grade I open tibial shaft fractures) Navicular bone in the wrist (also called scaphoid) Fresh, closed posteriorly displaced distal radius fractures (Colles fracture) Fractures associated with extensive soft tissue or vascular damage Bone Growth Stimulators, Electrical and Ultrasonic May 15 3

4 Jones fracture (fracture of 5th metatarsal) II. Health Net, Inc. also considers non-invasive low intensity ultrasound bone growth stimulators medically necessary in skeletally mature adults when used as an adjunct to conventional management (including but not limited to closed reduction, cast immobilization) for the treatment of fresh fractures when there is high risk for delayed fracture healing or nonunion due to any of the following comorbities: Diabetes Severe osteoporosis Steroid therapy Currently smoking History of alcoholism Morbid obesity III. Health Net, Inc. considers non-invasive low intensity ultrasound bone growth stimulators medically necessary for non-unions of bones other than the skull or vertebrae (radius, ulna, humerus, clavicle, tibia, fibula, femur, carpal, metacarpal, tarsal or metatarsal) when all of the following criteria are met: At least three months have elapsed since the date of fracture and the initiation of conventional fracture treatments; and Serial radiographs confirm that no progressive signs of healing have occurred despite appropriate fracture care and must include a minimum of two sets of films, each including multiple views of the fracture site; and The fracture gap is one centimeter or less; and The nonunion is not due to malignancy. Footnotes: 1. Examples include Ultrasonic Accelerated Fracture or Sonic Accelerated Fracture Healing Systems (SAFHS) and chronic accelerated fracture healing system (Exogen 2000). 2. Skeletal maturity refers to a system of fused skeletal bones, this occurs at approximately 16 years of age for females and 18 for males 3. A fresh fracture is a fracture that has recently occurred and has not been treated, other than emergency splinting Not Medically Necessary Health Net, Inc. considers treatment with non-invasive, semi-invasive or the invasive methods of bone stimulation not medically necessary for any of the following: 1. Concurrent usage of ultrasound device with an electrical device; or 2. Pathological fractures due to malignancy (unless the neoplasm is in remission); or Bone Growth Stimulators, Electrical and Ultrasonic May 15 4

5 3. Treatment of delayed unions, defined as a decelerating healing process as determined by serial x-rays; or 4. Open compound fractures that require surgical intervention or otherwise are too unstable for closed reduction/casting; or 5. Stress Fractures (because the medical literature does not support its use for this indication) 6. Fractures or nonunions of the axial skeleton (skull and vertebrae); or 7. Treatment of fresh fractures unless specified as above; or 8. Degenerative disease of the hip post-osteotomy; or 9. Non-traumatic avascular necrosis of the femoral head; or 10. Treatment of longstanding fractures older than five years; or 11. Fracture of short bones or epiphyses; or 12. Fractures that need additional reduction or are comminuted; or 13. Fractures with post-reduction displacement of > 50%; or 14. Congenital pseudoarthroses; or 15. Closed fresh fractures with open reduction; or 16. Internal fixation or external fixation;* 17. Fracture gaps > 1 centimeter; or 18. Infantile nonunion or failed joint fusion resulting from failed arthrodesis of the ankle or knee; or 19. Severe osteoporosis; or 20. A compliance monitor; or 21. Usage of direct current stimulation; or 22. Osteomyelitis, active infections or necrotic bone; or 23. Patients with cardiac pacemakers should consult their cardiologist before using either device; or 24. Patients with spondylitis or Paget s disease; or 25. Sensory paralysis; or 26. Synovial pseudoarthritis; or 27. Charcot osteoarthropathy; or 28. Post operative following bunionectomy due to lack of evidence in the peer review literature demonstrating its efficacy; or 29. As an adjunct to cervical fusion surgery and for failed cervical spine fusion (e.g. Cervical-Stim). Bone Growth Stimulators, Electrical and Ultrasonic May 15 5

6 *NOTE: The application of physical fields (magnetic, electrical, sonic) such as that from bone growth stimulators, has been shown to be an effective treatment option to enhance bone growth and healing. Nonunions with a large gap or synovial pseudarthrosis are thought to be better treated with bone grafting and internal fixation before electrical stimulation. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes Malunion Of Fracture Nonunion Of Fracture Closed Fracture Of Upper Humerus Closed Fracture Of Shaft Or Unspecified Part Of Humerus Closed Fracture Of Lower End Humerus Closed Fracture Of Upper End Of Radius And Ulna Closed Fracture Of Shaft Of Radius Or Ulna Closed Fracture Of Lower End Of Forearm Closed Fracture Of Unspecified Part Of Forearm Closed Fracture Of Unspecified Intracapsular Section Transcervical Fracture, Closed Pertrochanteric Fracture, Open Fracture Of Unspecified Part Of Neck Of Femur, Closed Fracture Of Unspecified Part Of Neck Of Femur, Open Closed Fracture Of Shaft Or Unspecified Part Of Femur Closed Fracture Of Lower End Of Femur Closed Fracture Of Upper End Of Tibia And Fibula Closed Fracture Of Shaft Of Tibia And Fibula Closed Fracture Of Unspecified Part Of Tibia And Fibula Closed Fracture Of Metatarsal Bone(s) ICD-10 Codes (May not be all inclusive; Add appropriate 7 th character to indicate nonunion or malunion) M96.0 Psuedarthrosis after fusion or arthrodesis S S42.92 Fracture of shoulder and upper arm S S52.92 Fracture of forearm S S62.92 Fracture at wrist and hand level S Bone Growth Stimulators, Electrical and Ultrasonic May 15 6

7 S72.92 Fracture of head and neck of femur S S82.92 Fracture of lower leg, including ankle S S92.92 Fracture of metatarsal bones Z98.1 Arthrodesis status CPT Codes Electrical stimulation to aid bone healing; noninvasive (nonoperative) Electrical stimulation to aid bone healing; invasive (operative) Low intensity ultrasound stimulation to aid bone healing, noninvasive, nonoperative HCPCS Codes E0747 E0748 E0749 E0760 Osteogenesis stimulator, electrical, noninvasive, other than spinal applications Osteogenesis stimulator, electrical, noninvasive, spinal applications Osteogenesis stimulator, electrical, surgically implanted Osteogenic stimulator, low intensity ultrasound, noninvasive Scientific Rationale Update May 2015 Orthofix International has its headquarter in Lewisville, Texas, and is a medical device company focused on providing reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. This company also has business units that include BioStim, Biologics, Extremity Fixation and Spine Fixation. Cervical-Stim is the only osteogenesis stimulator approved by the U.S. Food and Drug Administration (FDA) on December 23, 2004, as a noninvasive, adjunctive treatment option for cervical fusion. The device uses pulsed electromagnetic field (PEMF) technology to increase fusion success in patients at high risk for non-fusion. Per the manufacturer, Cervical-Stim has an overall clinical success rate of 84 percent, Cervical-Stim increases fusion success significantly by 22 percent when used adjunctively to surgery. An electrical osteogenesis stimulator is a device that provides electrical stimulation to augment bone repair. A noninvasive electrical stimulator is characterized by an external power source which is attached to a coil or electrodes placed on the skin or on a cast or brace over a fracture or fusion site. Bone growth stimulation is utilized to promote bone healing in difficult to heal fractures or fusions by applying electrical or ultrasonic current to the fracture/fusion site. There are three types of noninvasive electrical bone growth stimulators: 1. Capacitive coupling (CC) devices CC devices use metal electrodes, which are applied to the skin to deliver the current. An example of a CC device includes, but may not be limited to the EBI OrthoPak 2 Bone Growth Stimulator. 2. Pulsed electromagnetic field (PEMF) devices PEMF devices use an externally applied coil to deliver the current, which can be pulsed on and off. Examples of PEMF devices include, but may not be limited to the EBI Bone Healing System, the Orthofix Cervical- Stim, the Orthofix Physi-Stim, the Orthofix Spinal-Stim and the SpinalPak II Spinal Fusion Stimulator. Bone Growth Stimulators, Electrical and Ultrasonic May 15 7

8 3. Combined magnetic field (CMF) devices CMF devices use an external coil system with a combination of direct and alternating current to produce both static and alternating magnetic fields. Examples of CMF devices include, but may not be limited to the OrthoLogic (OL) 1000 Bone Growth Stimulator and the SpinaLogic Bone Growth Stimulator. Noninvasive bone growth stimulators that have received FDA PMA include: The SpinalPak bone growth stimulator system from Biolectron (a subsidiary of Electro-Biology Inc., Parsippany, NJ) is a capacitive coupling system, received PMA in 1999 for use as an adjunct to primary lumbar spinal fusion at one or two levels. The EBI Bone Healing System from Bioelectron (a subsidiary of Electro- Biology Inc., Parsippany, NJ) is a pulsed electromagnetic field system which was first approved in 1979 with FDA PMA and indicated for nonunions, failed fusions, and congenital pseudarthroses. The device is secured with a belt around the waist. SpinaLogic Bone Growth Stimulator (Regentek, a division of dj Orthopedics [formerly OrthoLogic, Tempe, AZ]) received PMA in 1994 as a combined magnetic field portable device. This device is secured with a belt around the waist. Spinal-Stim Lite (Orthofix Inc., Richardson, TX) received PMA in 1996 as a spinal adjunct to the Physio-Stim. This device was approved to increase the probability of fusion success and as a nonoperative treatment for the salvage of failed spinal fusion, where a minimum of 9 months has elapsed since the last surgery. The Cervical-Stim (Orthofix Inc., Richardson, TX) is a pulsed electromagnetic field system that was approved in 2004 as an adjunct to cervical fusion surgery in patients at high risk for non-fusion. There is one RCT regarding the Cervial-Stim that was completed by Foley et al. (2008), and it is noted in the Scientific Rationale Update for June This study in noted on the FDA site and is called the Cervical-Stim clinical study. There is a Clinical Trial on Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields that is enrolling participants by invitation only. The ClinicalTrials.gov Identifier is NCT and it was last updated in November The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing, compared with standard conservative care, in subjects 50 years of age and over diagnosed with Type II odontoid fractures, and this effect will be evident by 6 months post-injury. Subjects will be assessed for the presence of a Type II odontoid fracture by X-ray, MRI and CT scan. Subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active: placebo control) to either the active or control device for 4 hours a day for 6 months. X-rays will be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture healing process, with flexionextension x-rays collected at 3, 6 and 12 months. A CT scan will be performed at 6 months to confirm healing. Quality of Life measures (SF-36, VAS neck pain scale, NDI) will be collected at all visits (6 weeks, 3, 6 and 12 months). Study subjects will receive either an active Orthofix Cervical-Stim Model 2205OD or an inactive (placebo) Orthofix Cervical-Stim Model 2205OD device. The estimated study completion date is July Kaiser et al. (2014) completed a guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. The relationship between the formation of a solid arthrodesis and electrical and electromagnetic energy is well Bone Growth Stimulators, Electrical and Ultrasonic May 15 8

9 established. However, most of the information on the topic pertains to the healing of long bone fractures. The use of both invasive and noninvasive means to supply this energy and supplement spinal fusions has been investigated. Three forms of electrical stimulation are routinely used: direct current stimulation (DCS), pulsed electromagnetic field stimulation (PEMFS), and capacitive coupled electrical stimulation (CCES). Only DCS requires the placement of electrodes within the fusion substrate and is inserted at the time of surgery. Since publication of the original guidelines, few studies have investigated the use of bone growth stimulators. Based on the current review, no conflict with the previous recommendations was generated. The use of DCS is recommended as an option for patients younger than 60 years of age, since a positive effect on fusion has been observed. The same, however, cannot be stated for patients over 60, because DCS did not appear to have an impact on fusion rates in this population. No study was reviewed that investigated the use of CCES or the routine use of PEMFS. A single low-level study demonstrated a positive impact of PEMFS on patients undergoing revision surgery for pseudarthrosis, but this single study is insufficient to recommend for or against the use of PEMFS in this patient population. The American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) have updated their guidelines in 2014 and state that there is no evidence published after their 2005 guidelines that conflicts with the previous recommendations regarding bone growth stimulation. Based on a single level II study by Anderson et al. (2009), the routine use of direct current stimulation (DCS) in patients older than age 60 years was not recommended. Use of DCS was recommended as an option for patients younger than 60 years of age, based on level III and IV studies showing a positive impact on fusion rate. However, comments regarding the level III study were that it was a poorly designed and poorly conducted cohort study consisting of an exceedingly small heterogeneous population of patients, and the overall recommendation was level C. There was insufficient evidence to recommend for or against the use of pulsed electromagnetic field stimulation (PEMFS) as a treatment alternative to revision surgery in patients presenting with pseudoarthrosis following posterolateral lumbar fusion (PLF; singlelevel IV study). No additional studies investigating the efficacy of capacitive coupled electrical stimulation were identified. The 2005 AANS/CNS guideline stated that there is class II and III evidence (nonrandomized comparative trials and case series) to support the use of direct current stimulation or capacitative coupled stimulation for enhancing fusion rates in high-risk patients undergoing lumbar PLF. A beneficial effect on fusion rates in patients not at "high risk" has not been convincingly demonstrated, nor has an effect been shown for these modalities in patients treated with interbody fusion. There is limited evidence both for and against the use of PEMFS for enhancing fusion rates following PLF. Class II and III medical evidence supports the use of PEMFS for promoting arthrodesis following interbody fusion. Although some studies have purported to demonstrate functional improvement in some patient subgroups, other studies have not detected differences. All of the reviewed studies are significantly flawed by the use of a 4-point patient satisfaction scale as the primary outcome measure. This outcome measure is not validated. Because of the use of this flawed outcome measure and because of the conflicting results reported in the better designed studies that assess functional outcome, there is no consistent medical evidence to support or refute use of these devices for improving patient outcomes Scientific Rationale Update May 2014 Bone Growth Stimulators, Electrical and Ultrasonic May 15 9

10 The American Academy of Orthopedic Surgeons (AAOS, 2014), notes that Some nonunions can be treated nonsurgically. The most common nonsurgical treatment is a bone stimulator. This small device delivers ultrasonic or pulsed electromagnetic waves that stimulate healing The patient places the stimulator on the skin over the nonunion from 20 minutes to several hours daily. This treatment must be used every day to be effective. However, it also notes, Surgery is needed when nonsurgical methods fail. You may also need a second surgery if the first surgery failed. Surgical options include bone graft or bone graft substitute, internal fixation, and/or external fixation. The reference standard of treatment for nonunion fracture is considered to be open reduction with debridement of the nonunion, often with bone grafting, and external or internal fixation for stabilization. External fixation is a surgical treatment used to stabilize bone and soft tissues at a distance from the operative or injury focus. Internal fixation is the surgical implementation of implants for the purpose of repairing a bone. Electrical stimulation to hasten or facilitate the healing process for certain types of fractures can be attained either invasively, semi-invasively or noninvasively. Pulsed electromagnetic field therapy (PEMFT), also called pulsed magnetic therapy, pulse magnetotherapy, or PEMF, is a reparative technique most commonly used in the field of orthopedics for the treatment of non-union fractures, failed fusions, and congenital pseudarthrosis. Bone grafts or bone graft substitutes alone provide no stability to the fracture site. Unless the nonunion is inherently stable more surgical procedures may be necessary, such as internal or external fixation, to improve stability. EBI, a subsidiary of Biomet Inc., manufactures two FDA-approved implantable bone growth stimulators (OsteoGen and SpF Implantable Spine Fusion Stimulator) (FDA, 2009). According to information available from the manufacturer, the OsteoGen Bone Growth Stimulator, which was formerly the Osteostim device, manufactured by BGS Medical Corp., is indicated for the treatment of long bone nonunions. Variations of the OsteoGen device are available for high-risk fractures (i.e., OsteoGen Dual Lead Bone Growth Stimulator) and with mesh cathodes designed to provide scaffolding (i.e., OsteoGen-M Bone Growth Stimulator). The FDA defines a nonunion as a fracture acquired secondary to trauma that shows no visibly progressive signs of healing over a 3-month period. Two models of the SpF Implantable Spine Fusion Stimulator are available. The SpF PLUS-Mini model is indicated for spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels. The SpF-XL IIb model is indicated as a spinal fusion adjunct to increase the probability of fusion success in 3 or more levels. The FDA has also given premarket approval for the Zimmer Direct Current Bone Growth Stimulator (2009, Zimmer Inc.) Shi et al. (2013) completed a prospective, randomized controlled study, in which a total of 58 long-bone fracture patients, who presented with delayed union of between 16 weeks and 6 months, were randomly split into two groups and subjected to an early application of pulsed electromagnetic field (PEMF) or sham treatment. Clinical and radiological assessments were performed to evaluate the healing status. Treatment efficacy was assessed at three month intervals. Patients in the PEMF group showed a higher rate of union than those in the control group after the first three months of treatment, but this difference failed to achieve statistical Bone Growth Stimulators, Electrical and Ultrasonic May 15 10

11 significance. At the end of the study, PEMF treatment conducted for an average of 4.8 months led to a success rate of 77.4%. This was significantly higher than the control, which had an average duration of 4.4 months and a success rate of 48.1%. The total time from operation to the end of the study was a mean of 9.6 months for patients in the PEMF group. Fracture patients treated with an early application of PEMF achieved a significantly increased rate of union and an overall reduced suffering time compared with patients that receive PEMF after the 6 months or more of delayed union, as described by others. Boyette et al. (2012) Nonunion of fractures or osteotomies in the pediatric population is rare. The gold standard for the treatment of nonunions involves harvesting autologous iliac crest bone graft and sometimes internal fixation, which are invasive procedures. The purpose of this study was to evaluate the effectiveness of pulsed electromagnetic field on a non-united fracture or osteotomy in the pediatric population. A retrospective study was performed on all patients at the authors' institution who used pulsed electromagnetic field as part of their treatment for nonunion or delayed union. Success of the initial nonunion treatment was defined as complete union of the fracture or osteotomy site. Two types of treatment were administered once delayed bone healing was identified: pulsed electromagnetic field alone or pulsed electromagnetic field plus an adjunct treatment. Twenty-one patients were included; 8 osteotomies and 14 fractures developed a nonunion. Average patient age was 11.7 years. Average age for patients who healed with the initial treatment was 10.7 years, whereas nonhealers had an average age of 14 years. Eighty-nine percent of osteotomy nonunions healed with their first management. Fifty-seven percent of fracture nonunions healed at the first attempt. The use of pulsed electromagnetic field is a good option for the initial treatment of pediatric nonunions, especially for patients who develop nonunions secondary to osteotomies. Adding bone marrow aspiration improves the outcomes and is minimally invasive compared with autologous iliac crest bone graft, with no complications. The National Institute for Health and Clinical Excellence (NICE, 2013) issued a medical technology guidance focusing on outcome evidence (and cost savings compared to other treatment modalities) for use of the Exogen ultrasound bone healing system for long bone fractures with nonunion or delayed healing. For nonunion of long bone fractures (failure to heal after 9 months) the case for adopting the Exogen ultrasound bone healing system is supported by the clinical evidence, which shows high rates of fracture healing." For long bone fractures with delayed healing, NICE found the outcomes after treatment with the Exogen more difficult to interpret." Uncertainties exist, both with and without use of the Exogen ultrasound bone healing system, including the rate at which healing progresses between three and nine months after fracture and also the proportion of individuals in whom surgery would be avoided, because some long bone fractures heal spontaneously. The NICE guidance noted that the clinical evidence comparing the efficacy of the Exogen ultrasound bone healing system with surgery was very limited, recognizing the difficulties in conducting comparative studies, especially randomized controlled trials, to collect data on healing rates. These and other considerations influenced NICE's recommendation that use of the Exogen ultrasound bone healing system to treat long bone fractures with delayed healing was not supported by the current evidence. Scientific Rationale Update June 2012 Noninvasive electrical stimulators are located externally and deliver electrical current via pulsed electromagnetic field (PEMF), capacitive coupling, or combined (electro) Bone Growth Stimulators, Electrical and Ultrasonic May 15 11

12 magnetic field (CMF) technology. Studies have shown that pulsed electromagnetic field (PEMF) stimulation increases arthrodesis rates after lumbar spine fusion surgery (e.g., Linovitz et al 2002, Goodwin et all 1999, Mooney 1990), but there is a paucity of data concerning the effect of PEMF stimulation on cervical spine fusion. At the present time, there is currently only one device FDA approved for adjunctive treatment for the cervical spine after fusion surgery. Cervical-Stim (Orthofix) is a noninvasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high risk for nonfusion. Per the FDA, The Cervical-Stim is an external, low-level, pulsed electromagnetic field (PEMF) device. It is a single piece device that is lightweight, flexible and portable allowing freedom of movement during treatment. Colored lights and an alarm provide information during treatment (e.g. device is on, normal operation, battery low). The Cervical-Stim is made up of a control unit and a treatment transducer. The control unit contains a microprocessor that generates the Cervical-Stim electrical signal. That signal is convented to a highly uniform, low-energy magnetic field by the treatment transducer. When the device is centered over the treatment area, the therapeutic PEMF signal is delivered directly to the fusion site. To ensure that the device is functioning properly, the Cervical-Stim constantly monitors battery voltage and the electrical signal. If at any time during treatment, the device stops functioning properly, the red light will come on and the device will not provide treatment. The Cervical-Stim is powered from a single 9-volt disposable battery. When the red light flashes and the alarm sounds, the battery needs to be replaced. The device will provide approximately 5 days of treatment on one battery. Orthofix will provide a supply of batteries adequate to cover the patient's treatment time. The device is intended to be worn for 4 hours per day for 3 months or until fusion occurs. Foley et al (2008) sought to determine the efficacy and safety of PEMF stimulation as an adjunct to arthrodesis after ACDF in patients with potential risk factors for nonunion in a randomized, controlled, prospective multicenter clinical trial. Three hundred and twenty-three patients with radiographic evidence (computed tomography-myelogram [CT-myelo] or magnetic resonance imaging [MRI]) of a compressed cervical nerve root and symptomatic radiculopathy appropriate to the compressed root that had failed to respond to nonoperative management were enrolled in the study. The patients were either smokers (more than one pack per day) and/or were undergoing multilevel fusions. All patients underwent ACDF using the Smith-Robinson technique. Allograft bone and an anterior cervical plate were used in all cases. Measurements were obtained preoperatively and at each postoperative interval and included neurologic assessment, visual analog scale (VAS) scores for shoulder/arm pain at rest and with activity, SF-12 scores, the neck disability index (NDI), and radiographs (anteroposterior, lateral, and flexionextension views). Two orthopedic surgeons not otherwise affiliated with the study and blinded to treatment group evaluated the radiographs, as did a blinded radiologist. Adverse events were reported by all patients throughout the study to determine device safety. Patients were randomly assigned to one of two groups: those receiving PEMF stimulation after surgery (PEMF group, 163 patients) and those not receiving PEMF stimulation (control group, 160 patients). Postoperative care was otherwise identical. Follow-up was carried out at 1, 2, 3, 6, and 12 months postoperatively. The PEMF and control groups were comparable with regard to age, gender, race, past medical history, smoking status, and litigation status. Both groups Bone Growth Stimulators, Electrical and Ultrasonic May 15 12

13 were also comparable in terms of baseline diagnosis (herniated disc, spondylosis, or both) and number of levels operated (one, two, three, or four). At 6 months postoperatively, the PEMF group had a significantly higher fusion rate than the control group (83.6% vs. 68.6%, p=.0065). At 12 months after surgery, the stimulated group had a fusion rate of 92.8% compared with 86.7% for the control group (p=.1129). There were no significant differences between the PEMF and control groups with regard to VAS pain scores, NDI, or SF-12 scores at 6 or 12 months. No significant differences were found in the incidence of adverse events in the groups. The authors noted this is the first randomized, controlled trial that analyzes the effects of PEMF stimulation on cervical spine fusion. They concluded that PEMF stimulation significantly improved the fusion rate at 6 months postoperatively in patients undergoing ACDF with an allograft and an anterior cervical plate, the eligibility criteria being patients who were smokers or had undergone multilevel cervical fusion. At 12 months postoperatively, however, the fusion rate for PEMF patients was not significantly different from that of the control group. Patient compliance, which was automatically monitored by the device, was assessed at each visit; however, compliance data were not included in the paper. The large number of dropouts, non-significant difference in fusion rates by intent-totreat analysis, and lack of data on functional outcomes (e.g., pain, return to usual activity) limit interpretation of these study results. Scientific Rationale Update October 2010 Busse et al (2009) conducted a systematic review of randomised controlled trials evaluating the efficacy of low intensity pulsed ultrasonography for healing of fractures. Eligible studies included were randomised controlled trials that enrolled patients with any kind of fracture and randomly assigned them to low intensity pulsed ultrasonography or to a control group. Two reviewers independently agreed on eligibility; three reviewers independently assessed methodological quality and extracted outcome data. All outcomes were included and meta-analyses done when possible. 13 randomised trials, of which five assessed outcomes of importance to patients, were included. Moderate quality evidence from one trial found no effect of low intensity pulsed ultrasonography on functional recovery from conservatively managed fresh clavicle fractures; whereas low quality evidence from three trials suggests benefit in non-operatively managed fresh fractures (faster radiographic healing time mean 36.9%, 95% confidence interval 25.6% to 46.0%). A single trial provided moderate quality evidence suggesting no effect of low intensity pulsed ultrasonography on return to function among non-operatively treated stress fractures. Three trials provided very low quality evidence for accelerated functional improvement after distraction osteogenesis. One trial provided low quality evidence for a benefit of low intensity pulsed ultrasonography in accelerating healing of established non-unions managed with bone graft. Four trials provided low quality evidence for acceleration of healing of operatively managed fresh fractures. The authors concluded the evidence for the effect of low intensity pulsed ultrasonography on healing of fractures is moderate to very low in quality and provides conflicting results. Although overall results are promising, establishing the role of low intensity pulsed ultrasonography in the management of fractures requires large, blinded trials, directly addressing patient important outcomes such as return to function. Scientific Rationale Update September 2009 Acute metatarsal fractures occur as a result of direct or indirect mechanisms. Nondisplaced metatarsal fractures are generally treated without surgery. Treatment options for nondisplaced metatarsal fractures include compressive wraps, a supportive shoe, a medial longitudinal arch support with unloading of the metatarsal Bone Growth Stimulators, Electrical and Ultrasonic May 15 13

14 heads, a short leg cast, or a cast shoe. Minimally displaced or nondisplaced metatarsal fractures typically heal within 6 weeks and rarely create a functional deficit. Fractures of a single metatarsal shaft with lateral or medial displacement usually heal well without correction. These may be managed like nondisplaced fractures. However, if there is more than 3 to 4 mm displacement in a dorsal or plantar direction, or if dorsal/ plantar angulation exceeds 10 degrees, reduction is usually required. Displaced metatarsal fractures may require surgical treatment. Fractures of the base of the fifth metatarsal have been called Jones fracture. Fractures of the proximal fifth metatarsal diaphysis require more aggressive treatment, such as early surgical fixation or prolonged casting with no weight bearing. Early surgical fixation reduces time to healing. These fractures, are transverse and demonstrate a predilection for nonunion because of poor blood supply. The Jones fracture is known for prolonged healing time and non-union. No prospective randomized trial has defined optimal treatment of Jones fracture. Union rates with nonoperative treatment range from 72 to 93%. Delayed union has been reported with nonoperative management. Surgical intervention is considered for Hallux valgus deformity (bunion) when conservative measures fail to improve pain and dysfunction. Numerous surgical procedures for the correction of hallux valgus deformity have been described, including but not limited to, bunionectomy, osteotomy, arthroplasty, and rarely, arthrodesis. Few prospective, randomized trials evaluating these procedures have been performed. There lacks evidence from the peer review literature demonstrating that the use of non-invasive, semi-invasive or the invasive methods of bone stimulation improve patient outcomes following bunionectomy surgery. Scientific Rationale Update November 2008 Charcot arthropathy or neuropathy, also called Charcot joint or neuropathic joint, is a progressive deterioration of weight-bearing joints, usually in the foot or ankle. It is characterized by joint dislocations, pathologic fractures, and debilitating deformities. The common denominator in these various conditions is that motor function is not as severely affected as are sensory modalities in the patient. Any condition that causes sensory or autonomic neuropathy can lead to a Charcot joint. Charcot arthropathy occurs as a complication of diabetes, syphilis, chronic alcoholism, leprosy, meningomyelocele, spinal cord injury, syringomyelia, renal dialysis, and congenital insensitivity to pain. Diabetes is considered to be the most common cause of Charcot arthropathy. The Charcot foot in the diabetic patient is a progressive condition that is not confined to bones but affects all of the tissues in the lower extremity. It is often confused with osteomyelitis and massive infection of the foot necessitating early identification and management to prevent amputation of the lower extremity. The classical appearance of the acute Charcot foot is a warm, grossly edematous, erythematous, grossly deformed foot with rearfoot in valgus and forefoot adducted and elevated yet relatively painless foot in which pulses usually are palpable (edema permitting). Hypermobility of the affected joints/fractures may be found. Ulcerations are often found which may complicate treatment as an infection must be considered until proven negative. Radiographs can demonstrate the area of collapse, although the initial episode may consist of microfractures in which joint effusion is the only identifiable finding. The bone may look sclerotic and osteoporotic with multiple shards of bone. This presentation needs to be thought of as osteomyelitis with a high Bone Growth Stimulators, Electrical and Ultrasonic May 15 14

15 suspicion of Charcot foot until proven otherwise. With the advent of advanced surgical techniques and a better understanding, the physician may be optimistic with the treatment of this condition. By thoroughly understanding the etiologic factors and deforming forces, treatment can be planned for each specific patient. The exact nature of Charcot arthropathy remains unknown, but the following major theories exist regarding the pathophysiology of this condition: Neurotraumatic theory - This theory states that Charcot arthropathy is caused by an unperceived trauma or injury to an insensate foot. The sensory neuropathy renders the patient unaware of the osseous destruction that occurs with ambulation. This microtrauma leads to progressive destruction and damage to bone and joints. Neurovascular theory - This theory suggests that the underlying condition leads to the development of autonomic neuropathy, causing the extremity to receive an increased blood flow. This in turn results in a mismatch in bone destruction and synthesis, leading to osteopenia. Charcot arthropathy most likely results from a combination of the processes described in the above theories. The autonomic neuropathy leads to abnormal bone formation, and the sensory neuropathy leads to an insensate joint that is susceptible to trauma. The development of abnormal bone with no ability to protect the joint results in gradual bone fracture and in the subluxation of the joint. Managing the acute stage and ruling out infection is paramount. Debridement should be kept as minimal as possible. Biopsy of bone is the definitive test to rule out infection, while analysis of synovial tissue for shards of bone is diagnostic of a Charcot joint. Immediate immobilization and non-weight bearing is mandatory. The crumbled bone cannot be expected to consolidate and unite if the patient remains in a weight-bearing attitude. A relative osteopenia exists in the Charcot foot and the acute reaction following the joint collapse acts to further increase the local hyperemia and will promote further resorption of bone. Therefore, continued weightbearing in the acute phase may prevent healing or encourage additional breakdown even at sites other than the initial area. There were two small studies noted in the literature regarding the use of bone stimulation for charcot arthropathy. Hockenbury et al. (2007) reviewed the results of arthrodesis of the Charcot hindfoot when an implantable bone growth stimulator was added to the procedure. Arthrodesis of the Charcot hindfoot has a high non-union and complication rate. A total of 10 patients, 9 of whom were diabetic (aged 50 to 69 years) with Charcot neuroarthropathy of the ankle, hindfoot, or both had arthrodesis with use of rigid internal fixation and an implantable bone growth stimulator were included in the study. There were no amputations. Average American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score improved from 21 preoperatively to 59 post-operatively. The authors concluded that the adjunctive use of an implantable bone growth stimulator in conjunction with rigid internal fixation, autogenous bone grafting, and sound operative technique may enhance the outcome and fusion rate in patients undergoing arthrodesis for Charcot neuroarthropathy of the ankle and hindfoot. The findings of this study need to be validated by additional, larger, randomized, well-designed studies. Bone Growth Stimulators, Electrical and Ultrasonic May 15 15

16 Lau et al. (2007) evaluated the efficacy and morbidity of a surgically implanted direct current bone stimulator in 38 patients (40 feet) with fracture nonunion or at high risk for nonunion; 14 of these patients had Charcot (diabetic) neuroarthropathy. Union occurred in 26 (65%) of the 40 feet; complications other than nonunion occurred in 16 feet (40%). Two amputations (5%) were performed in cases of intractable neuritis and deep infection. Of the 6 cases of deep infection (15%), 5 resolved with device removal, and the sixth case required below-knee amputation. Use of a bone stimulator in patients with diabetes may be problematic, but the device did not have any adverse effects in other high-risk patients. A search focusing on implantable bone stimulators identified a small number of case series, all of which focused on foot and ankle arthrodesis in patients at high risk for non-union. Risk factors for non-union included smoking, diabetes mellitus, Charcot (diabetic) neuroarthropathy, steroid use and previous nonunion. No randomized clinical trial data was found. There is recent interest in the adjunctive use of bisphosphonate therapy in acute Charcot arthropathy to help expedite conversion of the acute process to the quiescent, reparative stage. Similarly, electrical bone growth stimulation has been applied to the management of acute neuroarthropathy to promote rapid consolidation of fractures. Low-intensity pulsed ultrasound (LIPUS) has also been suggested as a useful adjunct in promoting healing of Charcot fractures. Although promising in theory, none of these adjunctive treatments have yet been conclusively proven effective through large prospective multicenter, randomized trials. In summary, there is inadequate, randomized, scientific evidence in the peerreviewed medical literature to support the safety and efficacy for bone growth stimulator for charcot osteoarthropathy. Scientific Rationale Update May 2007 Per the Centers for Medicare and Medicaid Services, National Coverage Determination for Ultrasound Osteogenic Stimulators (150.2), CMS determines that the evidence is adequate to conclude that noninvasive ultrasound stimulation for the treatment of documented nonunion bone fractures, prior to surgical intervention, is reasonable and necessary, for Medicare members who meet specific criteria. This coverage position is noted for Medicare members only on this updated policy. Scientific Rationale Update April 2006 Delay or failure of healing in long bone fracture is a common clinical problem confronting the orthopedic surgeon, and can have significant impact on the quality of life for patients who have it. Handolin et al (2005) demonstrated that the specific ultrasound can effect healing rates similar to those achieved by surgical means, without the associated risks and complications, and to those achieved by electrical bone growth stimulation or by extracorporeal shock-wave therapy. Fujioka et al (2005) reported that 2 cases of nonunion of the hook of the hamate were treated with low-intensity pulsed ultrasound. The patients were baseball players and had been injured as a result of hitting repeatedly. Nonunion was detected on computed tomography (CT) and was exposed to ultrasound for 20 min a day for 4 months. In both cases, pain at the hypothenar eminence disappeared, and bone union was confirmed on CT at the end of the ultrasound treatment. Bone Growth Stimulators, Electrical and Ultrasonic May 15 16

17 Anglen (2003) reiterated in his review that, although regarded with skepticism by many physicians, there is abundant evidence from clinical studies of the effectiveness of ultrasound in speeding up healing. Dozens of retrospective reports, randomized, prospective, double-blind controlled trials have been published showing the efficacy of low intensity ultrasound for the treatment of long bone nonunion. Patients with unacceptable deformity, synovial pseudarthrosis, or large gaps are generally not good candidates for this treatment modality. Acknowledging that standard treatment for delayed union or nonunion of the scaphoid is operative management, Divelbiss and Adams (2001) summarized the use of low-intensity ultrasound as an adjunct to healing in fractures of the scaphoid, distal radius and tibia. Nolte et al (2001) studied ultrasound therapy in 29 patients with challenging, established nonunions. Daily, 20-minute applications of low-intensity ultrasound at the site of the nonunion were performed by the patients at home. Twenty-nine nonunion cases (86%) healed in an average treatment time of 22 weeks (median, 17 weeks). Analysis of the healed and failed outcome for age, gender, concomitant disease, bone location, fracture age, prior last surgery interval, nonunion type, smoking habits, and fixation before and during treatment showed a significant difference only in patients with a smoking habit. Scientific Rationale - Initial Electrical stimulation to hasten or facilitate the healing process for certain types of fractures can be attained either invasively, semi-invasively or noninvasively. Invasive devices provide electrical stimulation directly at the fracture site either through percutaneously placed cathodes or by implantation of a coiled cathode wire into the fracture site. The power pack for the latter device is implanted into soft tissue near the fracture site and subcutaneously connected to the cathode, creating a selfcontained system with no external components. The power supply for the former device is externally placed and the leads connected to the inserted cathodes. With the noninvasive device, opposing pads, wired to an external power supply, are placed over the cast. An electromagnetic field is created between the pads at the fracture site. Ultrasound bone growth stimulators are external DME devices that apply lowintensity, pulsed ultrasound to the skin surface above fracture sites. While the exact mechanism of ultrasound stimulation of bone healing is unknown, the theory is that the pressure waves it produces provides micro-mechanical stress and strain, causing biochemical alterations at the cellular level, which leads to enhanced bone formation. These devices consist of two main components: a signal generator and a small transducer connected by a cable to the generator. The transducer is applied to the skin over the fracture site. In October 1994, the Food and Drug Administration (FDA) approved the Sonic Accelerated Fracture Healing System (SAFHS), manufactured by Exogen, Inc. (West Caldwell, NJ), to accelerate the healing of new bone fractures in the tibial diaphysis and Colles' fractures of the distal radius in adults. The FDA approval of the device was based in part on its review of two multicenter randomized controlled trials of the device on tibial diaphyseal fractures and distal radius (Colles') fractures. SAFHS low intensity pulsed ultrasound has been demonstrated to significantly accelerate the time to clinical healing of fractures of the tibial diaphysis. Although SAFHS low intensity pulsed ultrasound has been demonstrated to accelerate the time to radiologic healing of fresh closed Colles' (wrist) fractures, it has not been shown to significantly reduce the time to clinical healing of these fractures. Bone Growth Stimulators, Electrical and Ultrasonic May 15 17

18 SAFHS low intensity pulsed ultrasound was approved by the FDA in February 2000 for the treatment of established nonunions, excluding the skull and vertebrae. The FDA approval of the device was based on a review of retrospective studies of 79 patients with nonunions treated with SAFHS. Patients with pathologic fractures due to malignancy were excluded from these studies. Of the 74 completed cases, 86% healed both radiographically and clinically and 14% were failures of SAFHS treatment. The mean time to a healed fracture was 5½ months. Other evidence of the effectiveness of SAFHS for nonunions include a registry of prescription use of SAFHS for nonunions in the United States, which showed a heal rate of 82% of 429 completed cases, and a retrospective study of nonunions which showed a heal rate of 90% of 30 completed cases. Review History January 2005 April 2006 May 2007 May 2008 November 2008 September 2009 October 2010 December 2011 June 2012 Medical Advisory Council initial approval Criteria for Ultrasound Bone Growth Stimulators revised Added coverage for noninvasive ultrasound stimulation for nonunion fractures prior to surgery for Medicare members when specific criteria is met. Combined commercial and Medicare criteria for ultrasound bone growth stimulators. Minor changes to the policy to aid in clarification of the criteria. Update. Revised policy to note treatment with non-invasive, semi-invasive or the invasive methods of bone stimulation as investigational and therefore not medically necessary, for the treatment of Charcot arthropathy. Added non-invasive, semi-invasive or the invasive methods of bone stimulation post-operatively following foot surgery unless criteria regarding non-union above is met (e.g., bunionectomy) To the investigational, not medically necessary section of the policy. Removed fracture of metatarsal (other than Jones fracture) and post-operatively after arthrodesis procedures associated with a high rate of nonunion, such as mid-foot procedures, from the list of medically necessary indications for ultrasonic bone growth stimulation. Update no revisions for commercial members. Added Medicare table and link to NCD. Update no revision Added treatment with non-invasive, semi-invasive or the invasive methods of bone stimulation not medically necessary as an adjunct to cervical fusion surgery and for failed cervical spine fusion (e.g. Cervical-Stim) July 2012 Update Under Not medically necessary section, # 28, revised statement to state BGS not medically necessary following bunionectomy July 2013 May 2014 May 2015 Update no revisions. Code updates Update Added Note under the Not Medically Necessary section: Fixation devices made from magnetic materials may compromise the effects of electric bone growth stimulators. Codes updated. Update no revisions. Codes updated. Bone Growth Stimulators, Electrical and Ultrasonic May 15 18

19 This policy is based on the following evidence-based guidelines: 1. FDA. Center for Devices and Radiological Health. Guidance document for industry and cdrh staff for the preparation of investigational device exemptions and premarket approval applications for bone growth stimulator devices. Updated April 24, Agency for Healthcare Research and Quality (AHRQ). The role of bone growth stimulating devices and orthobiologics in healing nonunion fractures. Technology assessment program. Prepared by ECRI Evidence-based Practice Center (EPC).September 21, Available at: 3. Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders: a clinical practice guideline. J Foot Ankle Surg 2006 Sep-Oct; 45(5): S2-66. (National Guideline Clearinghouse). 4. Hayes Health Technology Directory. Electrical Bone Growth Stimulation, Invasive. Sept Updated Sept Updated August Updated August 21, Hayes Health Technology Directory. Electrical Bone Growth Stimulation, Noninvasive. Sept Updated Sept Updated August Updated August 21, Archived October 14, American College of Foot and Ankle Surgeons. Fractures of Fifth Metatarsal. Last update Feb Available at: 7. Medical Technology Directory. Electrical Bone Growth Stimulation, Invasive Sept Updated Aug National Institute for Health and Clinical Excellence (NICE). Medical Technology Guidance 12 (MTG 12). EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing. January American Academy of Orthopedic Surgeons (AAOS). Nonunions. March Available at: 9. Hayes. Search & Summary. Trinity Evolution Bone Allograft (Orthofix Holdings Inc.). February 27, References Update May Clinicaltrials.gov. Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields. ClinicalTrials.gov Identifier:NCT November Kaiser, MG, Eck, JC, Groff, MW, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 17: bone growth stimulators as anadjunct for lumbar fusion. J Neurosurg Spine Jul;21(1): PMID: References Update May Bahrens SB, Deren ME, Monchik KO, et al. A Review of Bone Growth Stimulation for Fracture Treatment. Curr Orthop Pract. 2013;24(1): Griffin XL, Smith N, Parsons N, et al. Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev. 2012;2:CD Shi HF, Xiong J, Chen YX, et al. Early application of pulsed electromagnetic field in the treatment of postoperative delayed union of long-bone fractures: a prospective randomized controlled study. BMC Musculoskelet Disord Jan 19; 14: U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). PMA - Premarket Approval. Trade name: Exogen. Bone Growth Stimulators, Electrical and Ultrasonic May 15 19

20 5. Vanore JV, Christensen JC, Kravitz SR, et al. Diagnosis and treatment of first metatarsophalangeal joint disorders. Section 1: Hallux valgus. J Foot Ankle et al. References Update July Bae DS, Shah AS, Kalish LA, et al. Shoulder motion, strength, and functional outcomes in children with established malunion of the clavicle. J Pediatr Orthop Jul-Aug;33(5): Dodson NB, Ross AJ, Mendicino RW, Catanzariti AR. Factors affecting healing of ankle fractures. J Foot Ankle Surg Jan-Feb;52(1): Shibuya N, Humphers JM, Fluhman BL, Jupiter DC. Factors associated with nonunion, delayed union, and malunion in foot and ankle surgery in diabetic patients. J Foot Ankle Surg Mar-Apr;52(2): References Update July Assiotis A, Sachinis NP, Chalidis BE. Pulsed electromagnetic fields for the treatment of tibial delayed unions and nonunions A prospective clinical study and review of the literature. J Orthop Surg Res Jun 8;7(1):24 2. Bascarević ZLj, Vukasinović ZS, Bascarević VD, et al. Hallux valgus. Acta Chir Iugosl. 2011;58(3): References Update June Foley KT, Mroz TE, Arnold PM, et al. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. Spine J May-Jun;8(3): Goodwin CB, Brighton CT, Guyer RD, et al. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. Spine (Phila Pa 1976) Jul 1;24(13): Jenis LG, An HS, Stein R, Young B. Prospective comparison of the effect of direct current electrical stimulation and pulsed electromagnetic fields on instrumented posterolateral lumbar arthrodesis. J Spinal Disord Aug;13(4): Linovitz RJ, Pathria M, Bernhardt M, et al. Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo controlled study. Spine (Phila Pa 1976) Jul 1;27(13):1383-9; 5. Mackenzie D, Veninga FD. Reversal of delayed union of anterior cervical fusion treated with pulsed electromagnetic field stimulation: case report. South Med J May;97(5): Mooney V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions. Spine (Phila Pa 1976) Jul;15(7): U.S. FDA. Summary of Safetly and Effectiveness Data. Cervical-Stimig Model 505L Cervical Fusion System. Dec Available at: Google2&utm_source=fdaSearch&utm_medium=website&utm_term=cervicalstim&utm_content=3 References Update December 2011 Bone Growth Stimulators, Electrical and Ultrasonic May 15 20