Medscape: http://www.medscape.com/viewarticle/778366_print In the conclusion at the end, LIPUS scored slightly ahead of the competition.
A Review of Bone Growth Stimulation for Fracture Treatment Steve B. Behrens, Matthew E. Deren, Keith O. Monchik Curr Orthop Pract. 2013;24(1):84-91. Abstract Delay or failure of fracture healing is a common, significant clinical problem confronting orthopaedic surgeons. Treatment options consist of invasive surgical techniques, such as internal and external fixation, bone grafting, and more radically, amputation. Noninvasive options include bone growth stimulation. A PubMed search was performed for basic science and clinical articles regarding bone growth stimulation in the English language. Articles were assessed for study design, size, validity (with previously published literature), technology utilized, and method of treatment. The search identified articles from 1957 to present. These articles were reviewed, and ten additional references (i.e. book chapters) were analyzed as well. Metaanalysis of the data on bone growth stimulators for delayed and nonunion of fractures is difficult because of the heterogeneity of various trials and device specifications. Large, randomized, placebo-controlled trials are lacking, and much of the data reflect larger case series and comparative studies. Nevertheless, basic science and clinical evidence support the efficacy of bone growth stimulation as a fracture healing modality in the appropriate clinical situation. Introduction Nonunions An estimated six million fractures occur every year in the United States, with approximately 5% or 300,000 becoming nonunions. [1] Nonunions develop for a variety of reasons, including a large fracture gap, inadequate immobilization, malaligned fracture ends, infection, and inadequate vascular resources. In general, a nonunion is established when a fracture site shows no visible progressive signs of healing. The Health Care Financing Administration (Medicare) defines a nonunion and indications for bone growth stimulation as (1) nonunion of long bone fracture defined as radiographic evidence that fracture healing has ceased for 3 or more months before starting treatment with the osteogenesis stimulator, and (2) nonunion of long bone fracture documented by a minimum of two sets of radiographs obtained before starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days, each including multiple views of the fracture site, with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs. [2] Boyd et al. [3] investigated nonunions in 842 patients in 1965 and found a 35% incidence of nonunion in the tibia, 19% incidence in the femur, 7.5% in the humerus, 15.5% in the forearm, and 2% in the clavicle. In 1981, Connolly, [4] in a series of 602 patients, showed a much higher incidence of nonunion in the tibia (62%), femur (23%), humerus (7%), forearms (7%), and clavicle (1%), suggesting an increased frequency of tibial nonunion over time. The cost of a nonunion has been estimated between $23,000–$58,000, including initial surgery with grafting, frequent office visits, patient quality of life, and opportunity cost of missed work. [5] Treatment options consist of invasive surgical techniques, such as internal and external fixation, bone grafting, and in extreme cases, amputation. Noninvasive options include bone growth stimulation. Methods of Article Retrieval A PubMed search was performed for basic science and clinical articles regarding bone growth stimulation in the English language. Articles were assessed for study design, size, validity (with previously published literature), technology used, and method of treatment. The search identified articles from 1957 to present. These articles were reviewed, and ten additional references (i.e. book chapters) were analyzed as well. Meta-analysis of the data on bone growth stimulators for delayed and nonunion of fractures is difficult because of the heterogeneity of various trials and device specifications. Large, randomized, placebo-controlled trials are lacking, and much of the data reflect larger case series and comparative studies. History of Bone Growth Stimulation Christian Kratzenstein first described electricity for the treatment of rheumatism and the plague by using ''good electricity'' to replace ''bad electricity'' in 1744.6,7 Boyer described the effect of electricity on the healing of a tibial fracture in 1816. [8] By 1850, Mott [9] and Lente [10] documented the successful treatment of ununited fractures by electricity, and Garratt [11] later placed needles into a femoral fracture for healing. Wolff [12] published his chief premise in 1892, asserting that the architecture of living bone continuously adapts to surrounding operational stresses, which results in precise and efficient structural patterning. His work, now known as Wolff's Law, states that the structure of bone adapts to changes in its stress environment. The study of electricity and medicine continued into the 20th century, with Becker and Selden [13] exploring new pathways in the understanding of evolution, acupuncture, psychic phenomenon, and healing. In 1954, Fukada and Yasuda [14] published a study on the piezoelectric properties of dry bone and stress-generated electrical potentials directly relating to callus formation. [14] In 1962, Becker et al. [15] and Bassett et al., [16] described the electrical properties of hydrated bone, which was later confirmed by Friedenberg and Brighton [17] in 1966. Shamos and Lavine, [18] in 1967, investigated piezoelectric properties of biological tissues, and in 1968, Anderson and Eriksson [19] published their work on electrical properties of hydrated collagen, providing a working model for Wolff's Law. Different technology has been tested for the biophysical stimulation of bone formation, including extracorporeal shock-waves, [20] electrical and electromagnetic (capacitive coupling, combined magnetic fields, direct current, and pulsed electromagnetic fields), [21] laser, [22] mechanical, [23] and ultrasound. [24,25] Levels of Evidence and Recommendation Grading Identifying well-designed and unbiased clinical trials aids in decision-making for today's orthopaedic surgeons. Levels of evidence help to categorize trials and develop recommendations. Level I evidence consists of randomized controlled trials with significant difference, or those without significant difference but with narrow confidence intervals. [26] Also included are systematic reviews or meta-analyses of homogenous Level I trials. [26] Level II evidence consists of prospective cohort studies, randomized controlled trials of poor quality, and systematic review of Level II studies or nonhomogenous Level I trials. [26] Case-control studies, retrospective cohort studies, and systematic review of Level III studies comprises Level III evidence. [26] Level IV evidence is based on case series without control groups, or relies on historical control groups for comparison. [26] And finally, Level V evidence, consists of expert opinion. [26] Current Bone Growth Stimulator Technology Direct current (DC) in the 1960s through 1970s was the predecessor to modern day bone growth stimulator technology. DC stimulators consist of surgically implanted wire leads of various lengths placed directly at the fracture or fusion site. [21] Most commonly used during initial spinal fusion procedures,27 these stimulators also are implanted during fixation and bone grafting of nonunions. [28] A subcutaneous lithium battery powers the unit with 5–100 mA DC for 6 months, and is later removed during a second procedure. [21] Bone growth prevents the embedded wire leads from removal. DC stimulators provide constant uniform current at the target site during the entire battery life, eliminating concerns about patient compliance. [21] The disadvantages of DC stimulators are battery life of approximately 6-8 months, difficulty placing hardware, shortcircuits from leads touching other lead wires (or any metal), risk of infection, and a second procedure for hardware removal. [29] Modern stimulators can be classified into two groups: electromagnetic or ultrasound (). Electromagnetic stimulators are further divided into inductive or capacitive coupling devices. [28] Inductive coupling, otherwise known as pulsed electromagnetic fields (PEMF), was popularized in the 1970s, with over 250 published clinical research studies and 200 basic science studies supporting its efficacy. [1] The first PEMF device became available in 1979, and used an externally applied coil sized for fracture location. The unit may be used through or placed under casting material, with the patient wearing an external battery for up to 10 hours of daily use. [30] By creating an electrical signal in bone after energizing the coil, the device enhances the treatment of nonunions, using the bioelectrical principles of bone healing. [31] PEMFs create low-level electromagnetic signals, which after reaching a fracture site, are converted to electric currents. [32] It is thought that the PEMF mimics the body's normal physiologic processes. [31] The PEMF signal is a complex waveform that is often biphasic and quasirectangular, fluctuating in amplitude and frequency. [33] Patient noncompliance can be caused by the heavy weight of these units. Table 1. Types of bone stimulation technology Stimulator Advantages 30,31 Disadvantages 21,29–31 Direct current (DC) Patient compliance 6–8 month battery life Intraoperative hardware placement Short-circuits Infection risk Hardware removal Capacitive current (CC) Small and lightweight Daily battery changes Irritation of skin from electrodes Noninvasive Inductive current (IC) Placed under casting material Heavy unit weight Patient noncompliance Noninvasive Combined magnetic fields (CMF) 30 minutes of daily use Lack of supporting evidence in delayed Noninvasive Low-intensity pulsed ultrasound (LIPUS) Noninvasive Patient compliance Capacitive coupling (CC), popularized in the 1980s by Brighton and Pollack, [34] uses an external power source for frequencies of 20–200 kHz and fracture site electric fields of 1–100 mV/cm. [28,35] The external battery pack is connected to two wires and electrodes applied on the skin at the fracture site. [30] When using the unit for 24 hours, patients must change batteries daily. The units, though small and lightweight, may cause irritation of the skin from the electrodes. [31] Lorich et al.36 published an article on the biochemical pathways mediating the response of bone cells to CC, stating that this electrostimulation regulates gated ion channels to increase the flux of calcium within the cells. [36] The last electrical stimulator technology is a combined magnetic field (CMF) that became popular in the 1990s. The CMF technology combines a static DC electric field and a sinusoidal waveform [1] produced by external coils worn for 30 minutes daily. The ease and brevity of daily use may improve patient compliance for these devices. [31] Affecting cell signaling, likely through intracellular stores of calcium, these stimulators increase calmodulin levels and result in bone cell proliferation in vitro. [37] Low-intensity pulsed ultrasound (LIPUS) is a unique, noninvasive, and low-risk treatment option. LIPUS produces a mechanical signal which transmits through soft tissue and bone, producing micromotion at the fracture site detected by integrin cellular receptors. [12,38,39] Signaling through integrins results in increased expression of cyclooxygenase- 240, which leads to increased prostaglandin E-2 at the fracture site, and increased mineralization. [41] Micromotion also results from acoustic cavitation and shearing from LIPUS waves, causing fluid flow in the tissues and extracellular matrix [42] resulting in increased cell permeability, local blood pressure, and nutrient levels at the fracture site. [43] 44 LIPUS results in small increases in local temperature less than 11C, which may affect enzymes such as matrix metalloprotease-1, [45] and increase local blood flow to dissipate heat. [46] The increased angiogenesis may be prompted by increased cytokines, such as vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and interleukin-8 (IL-8). [47] Increased levels of intracellular Ca 2+ are critical to the cellular signaling stimulated by LIPUS. [48,49] Much literature has misconceived electrical current, not current density, as the essential factor in the efficacy of electrical stimulation. [50–52] The current density should not exceed 625 mA/in 2 to avoid bone degradation. [53] Each method of energy has benefits and potential drawbacks based on the component specification, such as size, weight, portability, patient compliance, and cost. Direct Current To our knowledge, no Level I evidence exists for the use of direct current (DC) in the treatment of fracture nonunions (), with the majority of published work being case series (Level IV). Based on the abundance of Level IV evidence, the use of direct current bone stimulation for treatment of fracture nonunion has a Grade C recommendation. In 1980, Paterson et al. [29] described the effective treatment of 84 long bone delayed unions and nonunions, using an implanted DC stimulator in a multicenter, retrospective case series. [29] Eighty-six percent of patients achieved fracture healing in the series, and the authors described the bone growth stimulator as particularly useful in cases refractory to bone grafting procedures and infections. However, they had no control group. Brighton et al. [54] later confirmed these findings, with a successful union rate of 72.5–83.7% in 258 nonunions treated with DC stimulators, mirroring outcomes of bone-graft surgery at the time of publication. Table 2. Evidence for bone stimulation use in Fractures Stimulator Level of evidence Grade of recommendation Direct current (DC) Level III-IV 29,54–59 C (delayed and nonunion) Capacitive current (CC) Level II-IV 34,60–62 B (delayed and Inductive current (IC) Level I-IV 63–78 C (delayed and nonunion) Combined magnetic fields (CMF) Level V 79 I (delayed and nonunion) Low-intensity pulsed ultrasound (LIPUS) Level I-IV 80–97 B (fresh fractures) C (delayed and nonunion) Most recently, Hughes and Anglin [55] reported a retrospective cohort of 111 patients with an implanted DC stimulator for nonunion and an 85% successful union rate. The authors reported significant complications if electrodes were implanted into deep soft tissue wounds or osteomyelitis. [55] Esterhai et al. [56] described difficulty in treating humeral nonunions with percutaneously implanted DC electrodes in 39 patients, with a 46% union rate. Heppenstall [57] reported an 85% success rate in a prospective case series of 40 tibial nonunions, with failures in patients with significant bone loss and undetected pseudarthrosis. [57] Bora et al. [58] published a 71% rate of union in 17 scaphoid nonunions treated with DC stimulation, and described less morbidity than the alternative iliac crest bone grafting of the time. Day [59] reported a case series of 16 nonunions treated by percutaneous DC electrodes that resulted in a 69% union rate. Inductive Coupling Much literature regarding bone growth stimulators involves inductive coupling, or PEMF. Based on the lack of highquality Level I data and preponderance of Level IV data, the use of PEMF for delayed unions and nonunions has a Grade C recommendation. The early investigator, Bassett et al. [63] first published the acceleration of fracture repair using electromagnetic fields, and the first clinical trial using this surgically noninvasive method was conducted in 1977. [64] In 1982, the confirmed final results of 1007 ununited fractures and 71 failed arthrodeses treated with PEMF by over 500 surgeons worldwide were published. [65] Seventy-five percent of 332 patients were effectively treated with PEMF, averaging 4.7 years disability, [3.4] previous operative failures, and with a 35% infection rate. A meta-analysis of four randomized, controlled trials for electromagnetic field stimulation for treatment of long-bone delayed unions and nonunions concluded that the effect of bone stimulation was small, not statistically significant, and provided insufficient evidence to make a definitive practice recommendation. [66] The heterogeneity of study designs and lack of functional outcome measures limited conclusions. Sharrard [67] published the results of 45 tibial shaft nonunions after initial conservative management in a multicenter, double-blinded trial. [67] After 12 weeks of PEMF or placebo stimulation, the authors found a statistically significant number of healed fractures by PEMF compared with controls after radiographic evaluation. The mean age of the treatment group was significantly lower than the control group (34.7–45.4 years), a possible cofounder in the results. A randomized, double-blinded, controlled trial by Borsalino et al. [68] was completed by 31 patients undergoing femoral intertrochanteric osteotomy for degenerative hip arthritis. At 90 days, increases in bone callus, callus density, and trabecular bridging were all statistically significant in the stimulated group. Barker [69] reported the results of 17 adults with tibial shaft nonunions treated with either PEMF or a control stimulator, reporting no significant differences between groups at 24 weeks. This study excluded a significant group of patients with sepsis, internal or external fixation, fracture gap greater than 0.5 cm, or operative procedure within 6 months. Heckman et al. [70] published a report on 149 patients treated with PEMF, noting a 64.4% success rate and the importance of anatomic location and patient compliance. Gossling et al. [71] published a comparison of surgery and PEMF for tibial fracture nonunion in 1992. After reviewing 44 articles, the authors concluded that PEMF treatment of nonunited tibial fractures is more successful than noninvasive management, and at least equally effective as surgery. Copious Level IV evidence exists for the use of PEMF in delayed and nonunited fractures. Meskens et al. [72] reported 67.7% successful unions in a case series with the use of PEMF in patients with nonunions, but reported unfavorable results in patients with atrophic nonunions or fractures of the humerus. In 57 tibial pseudarthroses treated with intramedullary nailing, PEMF increased the union rate from 83 to 91%, and decreased the time to union from 4.9 to 3.3 months. [73] The authors concluded that neither value was statistically significant. The results were clinically significant by a relative risk of 0.53, which confers a 47% reduction in the appearance of events. In a case series of proximal fifth metatarsal fractures treated with nonweightbearing cast immobilization and PEMF, all fractures healed within 3 months. [74] A follow-up study for scaphoid nonunions treated with PEMF showed a decreased successful union rate from the initially reported 80 to 69%, with only 50% of proximal pole fractures uniting, and decreased success in nonunions associated with avascular necrosis. [75] The authors concluded that PEMF should be a secondary alternative to traditional bone grafting. Colson et al. [76] published a prospective cohort of 33 longbone nonunions treated with either PEMF alone or combined with surgery, resulting in 83% and 100% unions, respectively. The authors noted the regimen of PEMF was simpler than prior studies but equally efficacious. PEMF used greater than 3 hours per day was 80% successful in 139 nonunions, compared with 35.7% successful unions in patients who used PEMF less than 3 hours per day. [77] Most recently, Assiotis et al. [76] reported a 77.3% fracture union rate in a prospective cohort of 44 tibial delayed unions or nonunions without infection. Capacitive Coupling (CC) Several Level II studies exist on the use of CC for treatment of delayed or nonunions, allowing for Grade B recommendation for its use. Brighton and Pollack [34] reported 77.3% successful fracture union by CC in 22 nonunions treated for an average of 22.5 weeks, with no effect on infection, previous recalcitrant nonunion, or prior internal fixation hardware. A prospective, double-blinded trial of established long-bone nonunion in 21 patients compared CC with placebo stimulation devices. [60] The successful union of 60% of fractures treated with CC was statistically significant compared with none of the placebo fractures achieving union, although the study was small in size and had a lower success rate compared with other studies. A case series of 22 nonunions with a 0.5 cm or larger fracture gap demonstrated 72.7% fracture union after an average of 26 weeks of CC stimulation. Higher success rates were found in metaphyseal rather than diaphyseal fractures. [61] Benazzo et al. [76] reported the results of a open study on the treatment of stress fractures in athletes by CC. Twenty-five lower limb stress fractures in 21 athletes were treated with a median stimulation time of 52 days. Twentytwo fractures healed, one did not heal, and two improved. The paper illustrated that CC could be safely used in athletes with stress fractures. Combined Magnetic Fields (CMF) A paucity of literature exists on the efficacy of CMF technology in human studies of bone healing, and insufficient evidence exists for recommendations on the use of CMF for delayed unions and nonunions. No human studies to date demonstrate the efficacy of CMF in nonunions or delayed unions. A double-blinded, randomized, placebo-controlled trial was performed on patients undergoing posterior spinal fusion, and showed accelerated healing on radiographs at 9 months in the experimental group compared to the control group. [79] Fusion rates were higher in the experimental group (64%) than the placebo group (43%), and women were shown to benefit greater from the stimulation. Low-intensity Pulsed Ultrasound A large number of clinical studies have examined the effects of LIPUS on fresh fractures, as well as delayed unions and nonunions. Overall, the evidence is Level II because of the heterogeneity of clinical trials and outcomes, with somewhat conflicting results as assessed by meta-analyses. LIPUS for the treatment of fresh fractures has a Grade B recommendation, while a Grade C recommendation can be made for its use in treating delayed or nonunited fractures. A meta-analysis of five randomized, controlled trials reported decreased time to union with LIPUS compared with placebo by 36 days in fresh fractures. [80] The authors concluded that these results should be interpreted with caution, as the pooled results failed tests for heterogeneity. A previous meta-analysis pooled three double-blind, randomized, placebo-controlled trials and reported that LIPUS significantly decreased time to union by 64 days on average. [81] Other authors have noted, however, that two of the three pooled trials were industry-supported, and the other trial had flaws in patient selection. [82] Another recent meta-analysis was unable to pool data for delayed and nonunited fractures treated with LIPUS, but reported that weak evidence exists for its use. [83] Bashardoust et al. [76] performed a meta-analysis of seven trials of LIPUS treatment of fresh fractures, reporting decreased time to healing compared with placebo. In 1994, Heckman et al. [76] reported the acceleration of tubercle fracture healing by LIPUS. In this randomized, controlled, double-blinded, multi-center center study, 33 fractures underwent ultrasound treatment compared with 34 placebo in acute, Grade 1, open tibia oblique or transverse fractures with less than 50 percent displacement. The treatment was 20 minutes per day until healing, which was defined as a three-cortices bridge. The results were a 38% faster healing time for fractures in the experimental compared with placebo patients. Patients undergoing ultrasound healed at 94 days, and patients receiving placebo at 154 days, which was statistically significant. The incidence of delayed union was reduced 83%. Older patients, younger patients, smokers, and nonsmokers saw decreased healing times of 65, 42, 72, and 33 days, respectively. In patients in whom there was a 2-mm gap, healing time decreased by 21 days. Patients with 3 to 4-mm gaps had a 58-day decrease and patients with a 5-mm gap had a 121-day decrease. .Strauss et al. [76] published a prospective, randomized, placebo-controlled study of 20 patients in which all 10 experimental patients treated by LIPUS healed by 8 weeks. In the placebo group, six healed by 13 weeks, eight healed by 16 weeks, and two had delayed unions defined as not healed by 20 weeks. The only critique in this study is its small sample size of only 10 patients in both the experimental and placebo groups. Kristiansen et al. [76] studied LIPUS in a randomized, doubleblinded, placebo-controlled trial of 60 patients with fresh metaphyseal distal radial fractures and reported significantly decreased time to union (61 days compared with 98 days) and decreased loss of reduction (20% compared with 43%) in those treated with LIPUS compared with placebo. Rue et al. [76] tested LIPUS against placebo in a randomized, double-blind trial of 43 tibial stress fractures in athletes and determined that LIPUS did not significantly reduce time to healing. A case series of five athletes with anterior midtibial stress fractures reported decreased pain and full return to activity at 3 months with LIPUS treatments. However, bony healing did not coincide with pain-free activity, and the authors urged close follow-up for treated patients. [88] A randomized, placebo-controlled trial reported decreased time to callus formation (9.5 to 6.5 weeks) and full weightbearing status (15.5 to 9.3 weeks) in complex tibial fractures when comparing placebo with LIPUS. [89] However, LIPUS did not demonstrate any increased fracture healing, resumption of activities of daily living, or pain scores when compared with placebo in a randomized, double-blind, controlled trial of 101 patients with fresh clavicular fractures. [90] Likewise, in lateral malleolar fractures treated with bioabsorbable fixation devices and randomized, double-blinded to treatment with placebo or LIPUS, Handolin et al. [76] did not observe a statistically significant difference in fracture healing despite a small trend towards increased callus in 12 weeks of follow-up. A multicenter, randomized, double-blinded, placebo-controlled trial of 91 patients with tibial nonunion demonstrated increased bone mineral density and decreased bone gap area with LIPUS treatment. [92] This study did not report functional outcomes or time to healing for either treatment group. Mayr et al., [93] in 2002, published on low-intensity ultrasound effectiveness for treating fracture healing disorders in a prospective case series of 100 nonunions. Inclusion criteria consisted of greater than 90 days from the last surgery or treatment change and 120 days since fracture. LIPUS treatment of 20 minutes per day was the only change in treatment. The authors reported an 86% rate of fracture healing. Patient selection was a shortcoming of this study, with the possibility that the sample of patients chosen might have been expected to respond well to treatment. Nolte et al. [76] published a study on LIPUS in a prospective case series of 29 nonunions: 5 atrophic, 12 hypertrophic, and 12 oligotrophic. The average fracture was 1.2 years old, the average time after prior surgery was 1 year, and the average number of previous surgeries was 1.4. Ultrasound was used for 20 minutes per day and was the only change in the treatment, resulting in 86% of cases healed. The average time to healing with ultrasound was 4 months, and 75% of smokers or ex-smokers had healed. Hemery et al. [76] reported a retrospective case series of 14 patients with surgically treated tibial nonunions, 11 of which reached union within 9 months of LIPUS treatment with no reported complications. 95 In a case series of 29 various nonunions treated with daily, 20-minute treatments of LIPUS, 25 fractures went on to union, with only tobacco use as a significant risk for failure to union after treatment. [94] Gebauer et al., [25] in 2005, published a prospective case series of 67 patients with nonunions that were stable, with no evidence of infection. [25] The minimal fracture age was 8 months; 4 months or more had passed since the date of last intervention, and radiographs demonstrated greater than 3 months with no evidence of healing. [25] Fractures were, on average, 39 months old, and patients averaged two prior failed surgeries. The ultrasound treatment was 20 minutes per day, resulting in 85% of fractures healed with an average of 168 days of treatment. Another cohort of 67 established nonunions were treated with LIPUS for an average of 168 days, with 85% successful healing, excluding malaligned, infected, segmental bone loss, or grossly unstable fractures. 25 Reanalysis of a multicentered cohort on LIPUS in long-bone fracture nonunions determined that the union rate was increased from 75% to 89.7% overall if treatment was started within 6 months of surgery. [96] A retrospective cohort of 71 tibial nonunions consequently treated with LIPUS demonstrated union in 73%, increased over the authors' quoted spontaneous union rate of 5–30%. [97] Comparing Technologies Few direct comparison studies exist to elucidate which technology to use in different clinical settings. Zorlu et al. [76] published a study of the effect of low-intensity ultrasound and percutaneous direct current for healing in rat fibular osteotomies. Both treatments improved healing, but there was no statistical significance between the two methods. Brighton et al., [99] in 1995, published a retrospective study on tibial nonunions treated with a DC, CC, or bone graft in a retrospective study of 271 tibial nonunions treated over 24 years. [71,99] The average duration of the nonunion was 23.5 months, ranging from 9–69 months. Seven risk factors were identified, and as more risk factors were present, the healing rate decreased regardless of treatments. In cases of previous bone graft failure, repeat grafting was also less likely to be successful with electrical treatment. In atrophic nonunions, CC treatment had a worse healing rate than grafting or DC treatment. Gossling et al. [71] compared surgery and PEMF in the treatment of nonunited tibial fractures. [71] They reviewed 42 articles, 14 using surgical treatment and 28 using PEMF. The overall treatment success rate from surgery was 82% in 258 tibias, while the overall treatment success rate for PEMF was 81% in 143 tibias. The success rate for nonunion surgery, therefore, drops dramatically with the successive number of operations, while it does not seem to affect the results of PEMF treatment. Conclusion For treatment of delayed unions and nonunions, DC, PEMF, and LIPUS bone stimulators have a Grade C recommendation, while CC technology has a Grade B recommenation. With regard to fresh fractures, LIPUS has a Grade B recommendation. Insufficient evidence exists for recommendation on CMF for fracture treatment. Insufficient evidence exists to recommend one stimulator over another. Further studies on the efficacy and cost-effectiveness of bone stimulators are warranted to better define the clinical implementation of these devices. References Ryaby JT. 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As the analysis points out. The LIPUS studies were " industry supported". They all, ( DJ Ortho excluded ) have the same efficacy. I like that Orthofix can be stocked and fitted over a splint in the hospital and the rep is right there to service.
Why on earth would you fit someone with that who is hospitalized with a splint? For an acute fracture??! Nice use of health care dollars there. Not to mention the commission for the prescribing Dr! Nice.
Non-union with osteopenia. OR a malunion\nonunion that had to be realigned and nonunion stimulated. Non-Union, it's indicated. No commission for Drs. Exogen, not indicated in acute fxs other than tibia or distal radius. Most of Exogen biz is in metatarsal fxs less than 90 days; a non indicated use. Despite what you are told; most fxs heal on their own.
