Coverage Policy Manual
Policy #: 1998023
Category: DME
Initiated: February 1998
Last Review: April 2024
  Low Intensity Pulsed Ultrasound Fracture Healing Device
Description:
An estimated 178 million new fractures were reported worldwide in 2019 (Wu, 2019). The majority of bone fractures heal spontaneously over several months following standard fracture care (closed reduction if necessary, followed by immobilization with casting or splinting). However, approximately 5-10% of all fractures have delayed healing, resulting in continued morbidity and increased utilization of healthcare services (Buza, 2016). Factors contributing to a nonunion include which bone is fractured, fracture site, the degree of bone loss, time since injury, the extent of soft tissue injury, and patient factors (e.g., smoking, diabetes, systemic disease) (Buza, 2016).
 
There is no standard definition of a fracture nonunion (Bhandari, 2012). The U.S. Food and Drug Administration (FDA) has defined nonunion as when "a minimum of 9 months has elapsed since injury, and the fracture site shows no visibly progressive signs of healing for a minimum of 3 months." Other definitions cite 3 to 6 months of time from the original injury, or simply when serial radiographs fail to show any further healing. These definitions do not reflect the underlying conditions in fractures that affect healing, such as the degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying bone stock.
 
Delayed union is generally considered a failure to heal between 3 and 9 months after fracture, after which the fracture site would be considered a nonunion. The delayed union may also be defined as a decelerating bone healing process, as identified in serial radiographs. (In contrast, nonunion serial radiographs show no evidence of healing). It is important to include both radiographic and clinical criteria to determine fracture healing status. Clinical criteria include the lack of ability to bear weight, fracture pain, and tenderness on palpation.
 
Low-intensity pulsed ultrasound has been proposed to accelerate healing of fractures. Low-intensity pulsed ultrasound is believed to alter the molecular and cellular mechanisms involved in each stage of the healing process (inflammation, soft callus formation, hard callus formation, and bone remodeling). The mechanism of action at the cellular level is not precisely known, but it is theorized that low-intensity pulsed ultrasound may stimulate the production or the activities of the following compounds that contribute to the bone healing process: cyclooxygenase-2, collagenase, integrin proteins, calcium, chondroblasts, mesenchymal cells, fibroblasts, and osteoblasts.
 
Low-intensity pulsed ultrasound treatment is self-administered, once daily for 20 minutes, until the fracture has healed, usually for 5 months.
 
 
Regulatory Status
In 1994, the Sonic Accelerated Fracture Healing System (SAFHS®; renamed Exogen 2000® and Exogen 4000+ now Exogen® Ultrasound Bone Healing System; Bioventus) was approved by the FDA through the premarket approval process for treatment of fresh, closed, posteriorly displaced distal radius (Colles) fractures and fresh, closed, or grade 1 open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. In February 2000, the labeled indication was expanded to include the treatment of established nonunions, excluding skull and vertebra. The AccelStim™ Bone Growth Stimulator (Orthofix US) was FDA approved in 2022 for accelerating time to healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed, or Grade I open tibial diaphysis fractures and for established non-unions in skeletally mature adults. FDA product code: LOF.
 
Note: Electrical stimulation of bone healing is considered separately in policy No.1997057.
Policy/
Coverage:
Effective August 2021
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Low-intensity pulsed ultrasound as a treatment of fresh fractures, fracture nonunion, delayed union fractures, stress fractures, osteotomy, distraction osteogenesis, or any other indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, low-intensity pulsed ultrasound as a treatment of fresh fractures, fracture nonunion, delayed union fractures, stress fractures, osteotomy, distraction osteogenesis, or any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to August 2021
 
Low-intensity pulsed ultrasound as a treatment of fresh fractures, fracture nonunion and delayed union fractures, stress fractures, osteotomy, distraction osteogenesis or any other indication does not meet member benefit certificate primary coverage criteria.
 
For members with contracts without primary coverage criteria, low-intensity pulsed ultrasound as a treatment of fresh fractures, fracture nonunion and delayed union fractures, stress fractures, osteotomy, distraction osteogenesis or any other indication is considered not medically necessary. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates.
 
Effective February 2017 – October 2017
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Low-intensity ultrasound treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when used as an adjunct to conventional management (i.e., closed reduction and cast immobilization) for the treatment of acute (defined as within 7 days after fracture occurs), closed fractures in skeletally mature individuals.
 
Low-intensity ultrasound treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a treatment of fracture nonunions of bones excluding the skull and vertebra when the following criteria are met:
 
    • At least 3 months have passed since the date of the fracture, AND  
    • Serial radiographs have confirmed that no progressive signs of healing have occurred, AND  
    • The fracture gap is 1 cm or less, AND  
    • The patient can be adequately immobilized and is of an age where he/she is likely to comply with non-weight bearing.  
 
Low-intensity ultrasound treatment as a treatment of delayed union of bones meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. Delayed union of bones is defined by the following criteria:
 
    • decelerating healing process as determined by serial radiographs, AND
    • a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 3 months from the index injury or the most recent intervention.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Other applications of low-intensity ultrasound treatment, including but not limited to treatment of open fractures, or congenital pseudoarthroses, is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, other applications of low-intensity ultrasound treatment, including but not limited to treatment of open fractures, or congenital pseudoarthroses, are considered investigational.  Investigational services are specific exclusions in most member benefit certificates of coverage.
 
Effective October 2012 – January 2014
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Low-intensity ultrasound treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when used as an adjunct to conventional management (i.e., closed reduction and cast immobilization) for the treatment of fresh, closed fractures in skeletally mature individuals.
 
Low-intensity ultrasound treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a treatment of fracture nonunions of bones excluding the skull and vertebra.  The following patient selection criteria are suggested, consistent with those proposed for electrical stimulation as a treatment of nonunions:
        • At least 3 months have passed since the date of the fracture, AND
        • Serial radiographs have confirmed that no progressive signs of healing have occurred, AND
        • The fracture gap is 1 cm or less, AND
        • The patient can be adequately immobilized and is of an age where he/she is likely to comply with non-weight bearing.
 
Low-intensity ultrasound treatment as a treatment of delayed union of bones meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
  
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Other applications of low-intensity ultrasound treatment, including but not limited to treatment of open fractures, or congenital pseudoarthroses, is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, other applications of low-intensity ultrasound treatment, including but not limited to treatment of open fractures, or congenital pseudoarthroses, are considered investigational.  Investigational services are specific exclusions in most member benefit certificates of coverage.
 
Effective prior October 2012
Low-intensity ultrasound treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when used as an adjunct to conventional management (i.e., closed reduction and cast immobilization) for the treatment of fresh, closed fractures in skeletally mature individuals.
 
Low-intensity ultrasound treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a treatment of fracture nonunions of bones excluding the skull and vertebra.  The following patient selection criteria are suggested, consistent with those proposed for electrical stimulation as a treatment of nonunions:
    • At least 3 months have passed since the date of the fracture, AND
    • Serial radiographs have confirmed that no progressive signs of healing have occurred, AND
    • The fracture gap is 1 cm or less, AND
    • The patient can be adequately immobilized and is of an age where he/she is likely to comply with non-weight bearing.
 
Other applications of low-intensity ultrasound treatment, including but not limited to treatment of delayed unions (defined as a decelerating healing process as determined by serial x-rays), open fractures, or congenital pseudoarthroses, is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, other applications of low-intensity ultrasound treatment, including but not limited to treatment of delayed unions (defined as a decelerating healing process as determined by serial x-rays), open fractures, or congenital pseudoarthroses, are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
Rationale:
LOW-INTENSITY PULSED ULTRASOUND
 
Systematic Reviews
A recently published systematic review by Schandelmaier et al (2017) provides the most comprehensive and rigorous overview and analysis of the existing evidence, including 26 randomized controlled trials (RCTs) that used low-intensity pulsed ultrasound (LIPUS) for bone healing (Schandelmaier, 2017).  There is a substantial degree of overlap in previously published systematic reviews or meta-analyses (TEC Assessment, 1995; Busse, 2009; Griffin, 2014; Schandelmaier, 2017; Seger, 2017). Therefore, we will primarily focus this review of evidence on the findings of Schandelmaier et al (2017) and highlight the results of RCTs identified to be of higher quality. The recently published meta-analysis by Seger et al (2017) analyzed healing index and average time to union following use of LIPUS in cases of scaphoid nonunion, but it did not report control group comparisons (Seger, 2017).
 
The study populations in RCTs included by Schandelmaier et al (2017) examined multiple types of fractures including patients with fresh fractures surgically managed (n=7), fresh fractures not surgically managed (n=6), distraction osteogenesis (n=5), nonunion fractures (n=3), osteotomy (n=3), and stress fractures (n=2). The RCTs had a median population size of 30 patients (range, 8-501 patients). The outcomes examined by this systematic review emphasized those outcomes reported by patients to be most important: functional recovery (eg, time to return to work, time to full weight bearing); pain reduction; and number of subsequent operations. Additional outcomes included time to radiographic healing, since this may be used by physicians to influence clinical decision making and adverse effects associated with LIPUS.
 
In this systematic review, 2 reviewers independently assessed the quality of the included RCTs, using GRADE, a modified Cochrane risk of bias tool. Generation of randomization sequence, concealment of allocation, and blinding of patients, caregivers, and outcome reporting were evaluated in each trial. Each outcome within each trial was assessed for blinding of outcome assessors, loss to follow-up, and additional limitations. Trial authors were contacted if there was uncertainty in the quality assessment. Of the 26 included trials, 6 were considered to have a low risk of bias, with the remaining 20 trials considered to have a high risk of bias. Reasons for high risk of bias designation included failure to report a method for allocation concealment (15 trials), high or unclear numbers of patients excluded from the analysis (13 trials), unblinded patients (10 trials), and unblinded caregivers or outcome assessors (10 trials). Of the 6 trials rated to be at low risk of bias, 4 were conducted in individuals with fresh fracture, 3 of which were operatively managed tibial fractures8,9 and one of which was nonoperatively managed clavicle fractures (Lubbert, 2008).The other 2 trials rated at low risk of bias included operatively managed mandibular fractures related to distraction osteogenesis (Schortinghuis, 2005; Schortinghuis, 2008).
 
None of the overall results from the meta-analysis (Schandelmaier, 2017)  demonstrated statistically significant differences supporting LIPUS. Variation in results was observed for days to full weight bearing, pain, or radiographic healing, and when only trials with low risk of bias were included, there was no difference between treatment and control groups.
 
Fresh Fractures
Surgically Managed
In 2016, Busse et al reported results from a concealed, blinded, sham-controlled, randomized trial evaluating LIPUS for the treatment of patients who underwent intramedullary nailing for fresh tibial fractures (Busse, 2016). The trial enrolled 501 patients; 250 received a LIPUS device, and 251 received a sham device. Treatment was self-administered for 20 minutes a day until there was radiographic evidence of healing. Coprimary end points were radiographic healing and return to function (as measured by the 36-Item Short-Form Health Survey [SF-36] Physical Component Summary score). Both radiographic and functional assessments had to show a clinically important effect for the results to be considered positive. All patients, clinicians, investigators, data analysts, and the industry sponsor were blinded to allocation until data analysis was complete. Patient compliance was considered moderate, with 73% of patients administering over half of all recommended treatments. There was no difference in time to radiographic healing between the treatment groups (hazard ratio, 1.07; 95% confidence interval [CI], 0.86 to 1.34; p=0.55). Moreover, there was no different in SF-36 Physical Component Summary scores (mean difference, 0.55; 95% CI, -0.75 to 1.84; p=0.41). A previously conducted pilot double-blind RCT by Busse et al (2014), including 51 subjects not assessed in the 2016 study, also did not find any statistically significant differences in pain reduction, subsequent operations, or radiographic healing time (Busse, 2014).
 
Emami et al (1999) conducted a double-blind, sham-controlled trial that randomized 32 patients with a fresh tibial fracture fixed with an intramedullary rod to additional treatment with an active (n=15) or inactive (n=17) LIPUS device (Emammi, 1999). LIPUS treatment began within 3 days of surgery (1 patient began treatment within 7 days of injury), and was self-administered for 20 minutes a day for 75 days. Radiographs were taken every third week until healing. Results showed that LIPUS did not shorten healing time based on any of the following measures: time to first visible callus (mean, 40 days, SD=3 for LIPUS vs 37 days, SD=3 for sham; p=0.44); time to radiographic healing assessed by radiologist (mean, 155 days, SD=days [median, 113 days] for LIPUS vs mean, 125 days, SD=11 [median, 112 days] for sham; p=0.76); and time to radiographic healing assessed by orthopedic surgeon (mean, 128 days, SD=13, for LIPUS and mean, 114 days, SD=9 for sham; p=0.40).
 
Nonsurgically Managed
Lubbert et al (2008) performed a multicenter, double-blind RCT (N=101) of LIPUS treatment of fresh (<5 days) clavicle shaft fractures (Lubbert, 2008). Patients used the LIPUS devices for 20 minutes once daily for 28 days and recorded their subjective feeling as to whether the fracture healed (the primary outcome measure), pain on visual analog scale, level of daily activities (hours of work, household work, sport), and analgesic use. Patient perception of the day the fracture healed was determined in 92 patients (47 active, 45 placebo); mean time to healing was 26.77 days in the active group and 27.09 days in the placebo group (p=0.91). Between-group differences regarding analgesic use and mean visual analog scale scores also did not differ significantly.
 
Section Summary: Fresh Fractures
Evidence for the use of LIPUS following fresh fracture, either surgically or nonsurgically managed, consists of a 2017 systematic review including 13 RCTs, 4 of which rated low risk for bias. The overall results of the systematic review and meta-analysis and particularly the results including only RCTs with a low risk of bias did not demonstrate statistically significant improvements for LIPUS on functional outcomes, pain, or radiographic healing time.
 
Fracture Nonunion or Delayed Union Fracture
The 2017 meta-analysis by Seger et al included 5 studies focused on scaphoid nonunions and analyzed healing index and average time to union following LIPUS.4 Among 166 cases in the analysis, 78.6% (range, 33%-100%) were reported to show healing following LIPUS with an average time to union of 4.2 months (range, 2.3-5.6 months). Comparative results were not the focus of the analysis.
 
The 2017 systematic review published by Schandelmaier included 3 RCTs in nonunion fractures that were operatively managed; however, all studies were rated at high risk of bias(Schandelmaier, 2017).  Schofer et al (2010) reported on a multicenter, randomized, double-blinded, sham-controlled trial of LIPUS in 101 patients with delayed union of the tibia (Schofer, 2010). Delayed union was defined as a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 16 weeks from the index injury or the most recent intervention. Roughly one-third of patients had an open fracture. Patients were randomized to LIPUS (n=51) or to an inactive sham device (n=50), to be administered 20 minutes a day for 16 weeks. The primary outcome was change in bone mineral density assessed by computed tomography attenuation coefficients. Gap area was a secondary outcome. Intention-to-treat analysis showed that LIPUS improved mean bone mineral density by 34% (90% CI, 14% to 57%) compared with sham treatment. The mean reduction in bone gap area was -0.13 mm2 in the LIPUS group and -0.10 mm2 in the sham group (effect size, -0.47; 95% CI, -0.91 to -0.03 mm2). At the end of 16 weeks, physicians judged 65% of patients in the LIPUS group healed and 46% of the patients in the sham group healed (p=0.07). This trial did not report functional outcomes or pain assessment limiting the utility of results.
 
Rutten et al (2012), published only as a thesis, reported on a blinded RCT with 20 subjects with tibial fracture nonunion that found a statistically significant reduction in time to radiographic healing (percent difference in days, -57.2%; 95% CI, -74.7% to -27.6%) (Rutten, 2012). However, there was a 45% loss to follow-up rate raising significant concerns about potential bias of these findings.
 
Ricardo et al (2006) published a blinded RCT in 21 subjects with scaphoid nonunion that also found a statistically significant reduction in time to radiographic healing (-40.4%; 95% CI, -48.7% to -30.8%) (Ricardo, 2006). Biglari et al (2016) conducted a prospective, single-institution, observational study on 61 nonunions in long bones of the lower extremity treated with LIPUS (Biglari, 2016). To be included in the study, patients could not have had an intervention at least 90 days before beginning LIPUS treatment. Successful therapy was defined as a radiographically confirmed consolidation and no further surgical revision needed for the next year. All patients were available for all follow-up visits. The average age of the patients was 45 years (range, 18-63 years). Twenty (32.8%) cases met the successful therapy definition. An analysis comparing successful and unsuccessful outcomes found that LIPUS was more beneficial in patients with a fracture gap size less than 1 cm, a fracture age of less than 6 months, and a low Non-Union Scoring System score.
 
Zura et al (2015) published an industry-sponsored analysis of the effect of LIPUS on patients with nonunion, defined as a failure to heal for more than 12 months using clinical and radiographic criteria (Zura, 2015).Patients were a subset in a U.S. Food and Drug Administration-required postmarket registry of consecutive patients who have used the Exogen LIPUS device. The registry had 1286 patients with nonunion. The analysis was performed on 767 (60%) records. Reasons for being excluded from the analysis included: 18% lost to follow-up, 9% for noncompliance, 8% withdrawals, and 5% other factors. The reported healing rate was 86.2% with the average time for healing 6.0 months.
 
Section Summary: Fracture Nonunion or Delayed Union Fracture
The evidence for LIPUS treatment of fracture nonunion consists only of lower quality and mostly uncontrolled studies including a 2017 meta-analysis without controlled comparison results, 3 RCTs at high risk of bias (one published as a thesis) and 2 observational studies (a prospective study and a registry study). Reported outcomes do not include functional outcomes, and a wide range of healing rates were reported across the studies with a lack of comparison with routine surgical care in the observational studies, limiting meaningful interpretation of these results.
 
Stress Fractures, Osteotomy Sites, or Distraction Osteogenesis
Rue et al (2004) reported on a double-blind RCT that examined the effects of 20 minutes of daily LIPUS on tibial stress fracture healing issues such as pain, function, and resumption of professional and personal activities in 26 military recruits (Rue, 2004). The delay from onset of symptoms to diagnosis was 32 days in the LIPUS group and 28 days in the placebo group. This trial found no significant difference in healing times between LIPUS treatment and sham, with a mean time of return to duty of 56 days for both groups. The trial was rated with a high risk of bias in the 2017 Schandelmaier meta-analysis (Schandelmaier, 2017).
 
In 2013, Urita et al published a small (N=27) quasi-randomized study (alternating assignment) of LIPUS after ulnar-shortening osteotomy for ulnar impaction syndrome or radial-shortening osteotomy for Kienböck disease (Urita, 2013).  Patients in the LIPUS group received a daily 20-minute treatment for at least 12 weeks postoperatively. Blinded evaluation of radiographic healing showed that LIPUS reduced the mean time to the cortical union by 27% (57 days vs 76 days) and endosteal union by 18% (121 days vs 148 days) compared with sham treatment. At the time of endosteal healing, the osteotomy plus LIPUS group and the osteotomy-only group had similar results, as measured using the Modified Mayo Wrist Score and no pain at the osteotomy site. The study was rated with a high risk of bias in the 2017 meta-analysis by Schandelmaier (Schandelmaier, 2017).
 
The 2017 systematic review by Schandelmaier included 6 trials of LIPUS for distraction osteogenesis following surgery and 4 of 6 studies were rated at high risk of bias (Schandelmaier, 2017).  Four studies were in the tibia, (Dudda, 2011; Salem, 2014; El-Mowafi, 2005; Tsumaki, 2004) and the other two were in the mandible (Schortinghuis, 2005; Schortinghuis, 2008). No clinically meaningful results were reported for the mandible studies in the meta-analysis (Schandelmaier, 2017). The remaining studies in the tibia were all unblinded. No statistically significant difference was noted in subsequent operations (relative risk, 0.63; 95% CI 0.13 to 2.99) as reported by Dudda et al (Dudda, 2011) in the meta-analysis (Schandelmaier, 2017).  Four of the studies (Dudda, 2014; Salem, 2014; El-Mowafi, 2005; Tsumaki, 2004)  were included in the metaanalysis  (Schandelmaier, 2017) for time to radiographic healing with mixed results, three not reporting statistically significant results.
 
Section Summary: Stress Fractures, Osteotomy Sites, or Distraction Osteogenesis
The evidence for LIPUS treatment of stress fractures, osteotomy sites, or distraction osteogenesis consists only of lower quality RCTs all rated to have a high risk of bias. Results do not generally include functional outcomes and results across various outcomes, primarily including time to radiographic healing, are inconsistent.
 
SUMMARY OF EVIDENCE
For individuals who have fresh fractures (surgically or nonsurgically managed) who receive low-intensity pulsed ultrasound (LIPUS), the evidence includes randomized controlled trials (RCTs) and a 2017 cumulative meta-analysis of RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. The evidence base has recently evolved with the publication of a large RCT and meta-analysis significantly shifting the weight of the evidence. Conclusions based on several earlier small RCTs, rated at high risk of bias, showed a potential benefit of LIPUS; however, the large RCT published in 2016, rated at low risk of bias, showed no benefit. A 2017 meta-analysis including only trials with low risk of bias found no difference in days to full weight bearing, pain reduction, or days to
radiographic healing. Similarly, the overall results of the meta-analysis found no significant difference in return to work, subsequent operations, or adverse effect. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
For individuals who have fracture nonunion or delayed union fracture who receive LIPUS, the evidence includes only lower quality studies including a small systematic review in scaphoid nonunions, 3 low-quality RCTs, and 2 observational studies. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. Reported outcomes in this subgroup of fractures do not include functional outcomes. A wide range of healing rates have been reported across the observational studies with a lack of comparison with routine surgical care, limiting any meaningful interpretation of these results. Additionally, the evidence base on the use of LIPUS in the management of fresh fractures has evolved as described above and there is no demonstrated physiologic mechanism suggesting differential results of
LIPUS in fracture nonunion or delayed union. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
For individuals who have stress fractures, osteotomy sites, or distraction osteogenesis who receive LIPUS, the evidence includes only lower quality studies including small RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. Results do not generally include functional outcomes and results across various outcomes, primarily time to radiographic healing, are inconsistent. Additionally, the evidence base on the use of LIPUS in the management of fresh fractures has evolved as described above and there is no demonstrated physiologic mechanism suggesting differential results of LIPUS in stress fractures, osteotomy sites, or distraction osteogenesis. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
PRACTICE GUIDELINES AND POSITION STATEMENTS
British Medical Journal Rapid Recommendation
The British Medical Journal (BMJ) Rapid Recommendations are a series of articles, produced by BMJ in collaboration with the MAGIC group,(MAGIC, 2017) to provide clinicians with practice guidelines. In 2017, BMJ Rapid Recommendations published guidelines on the use of e of low-intensity pulsed ultrasound (LIPUS) for bone healing (Poolman, 2017). The guidelines were based on a 2017 systematic review, which included 26 randomized controlled trials evaluating patients with fresh fractures not surgically managed, fresh fractures surgically managed, nonunion fractures, osteotomy, and distraction osteogenesis (Schandelmaier, 2017).  The committee concluded that there is “moderate to high certainty evidence to support a strong recommendation against the use of LIPUS for bone healing.” Furthermore, the guideline expert panel discussed whether the results of higher quality studies in patients with fresh fractures reported in Schandelmaier et al (2017) would apply to other types of fractures including nonunions and osteotomies (Schandelmaier, 2017).  “After extensive deliberations, the panel found no compelling anatomical or physiological reasons why LIPUS would probably be beneficial in these other patient populations” (Poolman, 2017).
 
National Institute for Health and Care Excellence
The U.K.’s National Institute for Health and Care Excellence (NICE) published guidance in 2010 on LIPUS to promote fracture healing (NICE, 2017).  NICE concluded that this procedure “can reduce fracture healing” and is particularly beneficial for “delayed healing and fracture non-union.”
 
In 2013, NICE published guidance on Exogen for the treatment of long bone fractures with nonunion and delayed fracture healing (NICE, 2013).  NICE concluded that use of the Exogen bone healing system to treat longbone fractures with nonunion is supported by “clinical evidence” and “cost savings … through avoiding surgery.” For long-bone fractures with delayed healing, defined as no radiologic evidence of healing after 3 months, there was “some radiologic evidence of improved healing.” However, due to “substantial uncertainties about the rate at which bone healing progresses without adjunctive treatment between 3 and 9 months after fracture” and need for surgery, “cost consequences” were uncertain. The next review by NICE of the Exogen system is scheduled to begin in April 2017.
 
American Academy of Orthopaedic Surgeons
The American Academy of Orthopaedic Surgeons published 2009 guidelines on the treatment of distal radius fractures (American Academy of Orthopaedic Surgeons, 2009). The Academy issued a limited recommendation for the use of LIPUS for adjuvant treatment of distal radius fractures. While evidence from 1 study demonstrated an increased rate of healing (measured by the absence of pain and radiographic union), the additional cost of LIPUS, resulted in a “limited” recommendation.
 
2018 Update
A literature search was conducted through July 2018.  There was no new information identified that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Fresh Fractures
Lou et al conducted a meta-analysis focusing on fresh fractures (Lou, 2017). The literature search, conducted through November 2016, included 12 studies, all of which were included in the Schandelmaier et al meta-analysis, except for a small study (N=20) by Strauss et al, which only appeared in a conference abstract (Schandelmaier, 2016; Strauss, 1999). Studies included patients that had been surgically managed and conservatively managed. Time to fracture union was significantly lower in patients receiving LIPUS than inpatients not receiving LIPUS (standard mean difference, -0.65; 95% 95% confidence interval [CI], -1.13 to -0.17). Subgroup analysis showed that this significant reduction in healing time with LIPUS was seen only among patients conservatively managed, while there was no difference in healing time among patients surgically managed. Reviewers concluded that patients with fresh fractures might benefit from the use of LIPUS but warned that there were methodologic limitations in the trials. Separate analyses using only low risk of bias trials was not conducted.
 
Tarride et al provided additional analyses using data from the TRUST trial, comparing health care resource use among patients using LIPUS with patients using the sham device (Tarride, 2017). There were no significant differences between groups (11% in patients receiving LIPUS vs 10% in patients receiving sham) in need for secondary procedures (eg, removal of lock screw, implant exchange or removal. There were also no statistically significant differences in use of physical therapy (44% vs 46%), use of anticoagulants (42% vs 36%), or use of nonsteroidal anti-inflammatory drugs (28% vs 35%) among patients receiving LIPUS compared with patients receiving sham, respectively.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Nolte et al conducted a retrospective comparison of patients with metatarsal fractures treated by LIPUS and by surgical techniques (Nolte, 2016). For the comparative analysis, patients from an FDA-required LIPUS registry (n=594) were propensity-matched 1:1 with patients treated surgically from a health claims database. The overall heal rates for all types of fractures combined was comparable for LIPUS (97%) and surgery (95%) (p=0.07). A subgroup analysis of patients with delayed or nonunion metatarsal fractures (n=226) also showed comparable rates of healing among the LIPUS group (96%) and the surgery group (96%).
 
Distraction Osteogenesis
Lou et al conducted a systematic review and meta-analysis on the use of LIPUS for the treatment of patients with distraction osteogenesis (Lou, 2018). The literature search, conducted in May 2018, identified 7 RCTs (172 patients) for inclusion. The Cochrane risk of bias tool was used to assess trial quality. Three of the trials were considered low risk of bias and 4 were considered to have high risk of bias. Main limitations in the trials were related to the lack of treatment allocation details and outcome assessors knowledge of treatment. Pooled results did not find statistically significant differences in: treatment time, radiological gap fill area, histological gap fill length, or bone density.
 
National Institute for Health and Care Excellence
In 2018, the National Institute for Health and Care Excellence (NICE) published a guidance on the use of LIPUS to promote healing of fresh fractures at low risk of non-healing (NICE, 2018). The guidance states that the "current evidence does not show efficacy. Therefore, this procedure should not be used for this indication."
 
In 2018, NICE published a guidance on the use of LIPUS to promote healing of fresh fractures at high risk of non-healing (NICE, 2018).The guidance states that the "current evidence on efficacy is very limited in quantity and quality. Therefore, this procedure should only be used in the context of research.
 
In 2018, NICE published a guidance on the use of LIPUS to promote healing of delayed and nonunion fractures (NICE, 2018). The guidance states that the "current evidence on efficacy is inadequate in quality. Therefore, this procedure should only be used with special arrangements for clinical governances, consent and audit or research."
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2020. No new literature was identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Gopalan et al conducted a single-blind RCT of low intensity pulsed ultrasound plus open reduction and internal fixation compared to surgery alone in 40 patients with mandibular fracture at a single surgical center in India (Gopalan, 2020). Patients who were randomized to the intervention group received low intensity pulsed ultrasound therapy at 4, 8, 14, and 20 days postoperatively, for 20 minutes daily. Postoperative examinations were performed 5, 9, 15, and 21 days to assess wound healing, pain, and teeth mobility. Assessment of orthopantomograms and ultrasound scans were blinded. Patients were not blinded, and it is unclear whether pain assessments were conducted by blinded outcome assessors. Pain scores were significantly lower in the treatment group compared to the control group at all assessment time points. Ultrasound assessments of fracture healing were significantly better in the treatment group at weeks 4, 8, and 12, but radiographic assessments of fracture healing did not differ between groups at any time point. Wound healing was significantly greater in the intervention group on postoperative day 5 and 9, but the difference was not significant on day 21. This study was limited by its small sample size, single center design, and lack of blinding of patients.
 
Song et al reported on a retrospective observational study of 30 patients who underwent tibial lengthening procedures at a single institution between October 2009 and October 2015 (Song, 2019). Fifteen patients who received low intensity pulsed ultrasound during distraction osteogenesis were compared to 15 patients who underwent the same procedure but did not receive low intensity pulsed ultrasound. During the distraction phase, calluses of the low intensity pulsed ultrasound group were more cylindrical, more homogeneous, and denser than those of the control group. At the time of external fixator removal, however, there were no significant differences between the groups in callus shape and type. There were no significant differences in external fixation index between the groups. There were 6 complications in the group who received low intensity pulsed ultrasound and 5 in the control group. No complications related to the low intensity pulsed ultrasound procedure were reported.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Leighton et al conducted a systematic review/meta-analysis that included patients with instrumented, infected, or fragility-related non-union in a systematic review of low-intensity pulsed ultrasound (Leighton, 2021). The study found non-union healing rates of 82% in patients with instrumentation or infection and 91% in patients with fragility fractures. Although the authors concluded the healing rates were comparable to a standard population of patients with non-union, the analysis consisted primarily of small case series limiting its role in the overall body of evidence.
 
In a retrospective study, Goshima et al compared 45 individuals treated with low-intensity pulsed ultrasound with 45 individuals who did not receive low-intensity pulsed ultrasound following open-wedge high tibial osteotomy (Goshima, 2022). The study included patients treated between 2012 and 2017 at a hospital in Japan. Treatment was applied for 20 minutes daily and continued for 3 months postoperatively or as judged sufficient by the study investigator. The lateral hinge united at 6 weeks in 73.3% of knees in the low-intensity pulsed ultrasound group and 75.6% in the control group. The VAS pain scores were statistically significantly improved in the low-intensity pulsed ultrasound group compared with control at 6 weeks and 3 months, but the numerical differences were small (32.2 vs. 38.7 and 27.5 vs. 36.4 at 6 weeks and 3 months, respectively). Mean Japanese Orthopaedic Association scores were not significantly different between groups at any time point. The authors concluded that their study does not support the use of low-intensity pulsed ultrasound in patients after open-wedge high tibial osteotomy.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2024. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
20979Low intensity ultrasound stimulation to aid bone healing, noninvasive (nonoperative)
E0760Osteogenesis stimulator, low intensity ultrasound, non invasive
References: Biglari B, Yildirim TM, Swing T, et al.(2016) Failed treatment of long bone nonunions with low intensity pulsed ultrasound. Arch Orthop Trauma Surg. Aug 2016;136(8):1121-1134. PMID 27383218

Accelerated fracture healing. 1995 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; tab 14.

American Academy of Orthopaedic Surgeons.(2017) The treatment of distal radius fractures. 2009; http://www.aaos.org/research/guidelines/drfguideline.pdf. Accessed January 30, 2017.

Bhandari M, Fong K, Sprague S, et al.(2012) Variability in the definition and perceived causes of delayed unions and nonunions: a cross-sectional, multinational survey of orthopaedic surgeons. J Bone Joint Surg Am. Aug 1 2012;94(15):e1091-1096. PMID 22854998

Biglari B, Yildirim TM, Swing T, et al.(2016) Failed treatment of long bone nonunions with low intensity pulsed ultrasound. Aug 2016;136(8):1121-1134. PMID 27383218

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC).(1995) Ultrasound accelerated fracture healing. TEC Assessments 1995;Volume 10:Tab 14.

Busse JW, Bhandari M, Einhorn TA, et al.(2014) Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study. Trials. 2014;15:206. PMID 24898987

Busse JW, Bhandari M, Einhorn TA, et al.(2016) Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. Oct 25 2016;355:i5351. PMID 27797787

Busse JW, Bhandari M, et al.(2002) The effect of low-intnsity pulsed ultrasound therapy on time to fracture healing: a meta-analysis. CMAJ 2002; 166:437-41.

Busse JW, Bhandari M, Kulkarni AV, et al.(2002) The effect of low-intensity pulsed ultrasound therapy on time to fracture healing: A meta-analysis. CMAJ 2002; 166:437-41.

Busse JW, Kaur J, Mollon B, et al.(2009) Low intensity pulsed ultasonography for fractures: systematic review of randomised controlled trials. BMJ 2009; 338:b351.

Buza JA, 3rd, Einhorn T.(2016) Bone healing in 2016. Clin Cases Miner Bone Metab. May-Aug 2016;13(2):101-105. PMID 27920804

Coverage Issues Manual. http://www.hcfa.gov/pubforms/06_cim/ci35.htm#_1_53. Accessed October 22 2000.

Dijkman BG, Busse JW, Walter SD et al.(2011) The impact of clinical data on the evaluation of tibial fracture healing. Trials 2011; 12:237.

Dudda M, Hauser J, Muhr G, et al.(2011) Low-intensity pulsed ultrasound as a useful adjuvant during distraction osteogenesis: a prospective, randomized controlled trial. J Trauma. Nov 2011;71(5):1376-1380. PMID 22071933

El-Mowafi H, Mohsen M.(2005) The effect of low-intensity pulsed ultrasound on callus maturation in tibial distraction osteogenesis. Int Orthop. Apr 2005;29(2):121-124. PMID 15685456

Emami A, Petren-Makknub M, Larsson S.(1999) No effect of low-intensity ultrasound on healing time of intramedullary fixed tibial fractures. J Orthop Trauma 1999; 13:252-7.

Emami A, Petren-Mallmin M, Larsson S.(1999) No effect of low-intensity ultrasound on healing time of intramedullary fixed tibial fractures. J Orthop Trauma. May 1999;13(4):252-257. PMID 10342350

Gopalan A, Panneerselvam E, Doss GT, et al.(2020) Evaluation of Efficacy of Low Intensity Pulsed Ultrasound in Facilitating Mandibular Fracture Healing-A Blinded Randomized Controlled Clinical Trial. J Oral Maxillofac Surg. Jun 2020; 78(6): 997.e1-997.e7. PMID 32145206

Goshima K, Sawaguchi T, Horii T, et al.(2022) Low-intensity pulsed ultrasound does not promote bone healing and functional recovery after open wedge high tibial osteotomy. Bone Jt Open. Nov 2022; 3(11): 885-893. PMID 36373863

Griffin XL, Parsons N, Costa ML, et al.(2014) Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev. 2014;6:CD008579. PMID 24956457

Griffin XL, Smith N, Parsons N et al.(2012) Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev 2012; 2:CD008579.

Griffin XL, Smith N, Parsons N, et al.(2012) Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev. 2012;2:CD008579. PMID 22336847

Hadjiargyrou M, McLeod K, Ryaby JP, Rubin C.(1998) Enhancement of fracture healing by low intensity ultrasound. Clin Orthop Rel Res 1998; 355S:S216-S229.

Hayes, Inc; October 2003.

Heckman JD, Ryaby JP, McCabe J et al.(1994) Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am 1994; 76(1):26-34.

Heckman JD, Ryaby JP, McCabe J, et al.(1994) Acceleration of tibial fracture healing by noninvasive, low intensity pulsed ultrasound. J Bone Jt Surg 1994; 76:26-34.

Heckman JD, Sarasohn-Kahn J.(1997) The economics of treating tibia fractures: the cost of delayed unions. Bull Hosp Jt Dis 1997; 56:63-72.

Jensen JE.(1998) Stress fracture in the world class athlete: a case study. Med Sci Sports Exer 1998; 783-787.

Kristiansen TK, Ryaby JP, McCabe J et al.(1997) Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am 1997; 79(7):961-73.

Kristiansen TK, Ryaby JP, McCabe J, et al.(1997) Accelerated healing of distal radial fractures with the use of specific, low intensity ultrasound. J Bone Jt Surg 1997; 79:961-973.

Leighton R, Phillips M, Bhandari M, et al.(2021) Low intensity pulsed ultrasound (LIPUS) use for the management of instrumented, infected, and fragility non-unions: a systematic review and meta-analysis of healing proportions. BMC Musculoskelet Disord. Jun 11 2021; 22(1): 532. PMID 34116673

Leighton R, Watson JT, Giannoudis P, et al.(2017) Healing of fracture nonunions treated with low-intensity pulsed ultrasound (LIPUS): A systematic review and meta-analysis. Injury. Jul 2017;48(7):1339-1347. PMID 28532896

Leung KS, Lee WS, et al.(2004) Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. Ultrasound Med Biol 2004; 30:389-95.

Lou S, Lv H, Li Z, et al.(2017) The effects of low-intensity pulsed ultrasound on fresh fracture: A meta-analysis. Medicine (Baltimore). Sep 2017;96(39):e8181. PMID 28953676

Lou S, Lv H, Li Z, et al.(2018) Effect of low-intensity pulsed ultrasound on distraction osteogenesis: a systematic review and meta-analysis of randomized controlled trials. J Ortho Surg and Research 2018; 13(1)205. PMID 30119631.

Lubbert PH, van der Rijt RH, Hoorntje LE et al.(2008) Low-intensity pulsed ultrasound (LIPUS) in fresh clavicle fractures: a multi-centre double blind randomised controlled trial. Injury 2008; 39(12):1444-52.

MAGIC: Making GRADE the Irrestible Choice. n.d.; www.magicproject.org. Accessed June 28, 2017.

MAGIC: Making GRADE the Irrestible Choice. n.d.; www.magicproject.org. Accessed June 28, 2017.

Marsh DR, Li G.(1999) The biology of fracture healing: optimizing outcome. Br Med Bull 1999; 55:856-869.

Mayr E, Frankel V, Rüter A.(2000) Ultrasound—an alternative healing method for nonunions. Arch Orthop Trauma Surg 2000; 120:1-8.

Mayr E, Rudzki MM, Rudzki M, et al.(2000) [Does low intensity, pulsed ultrasound speed healing of scaphoid fractures?]. Handchir Mikrochir Plast Chir. Mar 2000;32(2):115-122. PMID 10857066

National Institute for Health and Care Excellence (NICE).(2010) Low-intensity pulsed ultrasound to promote fracture healing [IPG 374]. 2010; https://www.nice.org.uk/guidance/ipg374/chapter/1-Guidance. Accessed January 30, 2017.

National Institute for Health and Care Excellence (NICE).(2018) Low-intensity pulsed ultrasound to promote healing of delayed-union and non-union fractures [IPG623]. 2018; https://www.nice.org.uk/guidance/ipg623. Accessed February 27, 2019.

National Institute for Health and Care Excellence (NICE).(2018) Low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing [IPG621]. 2018; https://www.nice.org.uk/guidance/ipg621. Accessed February 27, 2019.

National Institute for Health and Care Excellence (NICE).(2018) Low-intensity pulsed ultrasound to promote healing of fresh fractures at high risk of non-healing [IPG622]. 2018; https://www.nice.org.uk/guidance/ipg622. Accessed February 27, 2019.

National Institute for Health and Care Excellence.(2013) NICE medical technology guidance 12: EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing. 2013. Available online at: http://www.nice.org.uk/nicemedia/live/14018/62289/62289.pdf. Last accessed November, 2013.

Nolte, PP, Anderson, RR, Strauss, et al.(2016) Heal rate of metatarsal fractures: A propensity-matching study of patients treated with low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments. Injury, 2016 Nov 5;47(11). PMID 27641221.

Poolman RW, Agoritsas T, Siemieniuk RA, et al.(2017) Low intensity pulsed ultrasound (LIPUS) for bone healing: a clinical practice guideline. BMJ. Feb 21 2017;356:j576. PMID 28228381

Poolman RW, Agoritsas T, Siemieniuk RA, et al.(2017) Low intensity pulsed ultrasound (LIPUS) for bone healing: a clinical practice guideline. BMJ. Feb 21 2017;356:j576. PMID 28228381

Ricardo M.(2006) The effect of ultrasound on the healing of muscle-pediculated bone graft in scaphoid non-union. Int Orthop. Apr 2006;30(2):123-127. PMID 16474939

Rue JP, Armstrong DW 3rd, Frassica FJ et al.(2004) The effect of pulsed ultrasound in the treatment of tibial stress fractures. Orthopedics 2004; 27(11):1192-5.

Rutten S, Klein-Nulend J, Guit GL, et al.(2012) Use of low-intensity pulsed ultrasound stimulation of delayed unions of the osteotomized fibula: a prospective randomized double-blind trial. Low-intensity pulsed ultrasound treatment in delayed bone healing [thesis]. Amsterdam, the Netherlands: Vrije Universiteit Amsterdam; 2012.

Salem KH, Schmelz A.(2014) Low-intensity pulsed ultrasound shortens the treatment time in tibial distraction osteogenesis. Int Orthop. Jul 2014;38(7):1477-1482. PMID 24390009

Sanders R, Jersinovich I, Anglen J, et al.(1994) The treatment of open tibial shaft fractures using an interlocked intramedullary nail without reaming. J Ortho Trauma 1994; 8:504-510.

Schandelmaier S, Kaushal A, Lytvyn L, et al.(2017) Low intensity pulsed ultrasound for bone healing: systematic review of randomized controlled trials. BMJ. Feb 22 2017;356:j656. PMID 28348110

Schofer MD, Block JE, Aigner J et al.(2010) Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord 2010; 11:229.

Schortinghuis J, Bronckers AL, Gravendeel J, et al.(2008) The effect of ultrasound on osteogenesis in the vertically distracted edentulous mandible: a double-blind trial. Int J Oral Maxillofac Surg. Nov 2008;37(11):1014-1021. PMID 18757179

Schortinghuis J, Bronckers AL, Stegenga B, et al.(2005) Ultrasound to stimulate early bone formation in a distraction gap: a double blind randomised clinical pilot trial in the edentulous mandible. Arch Oral Biol. Apr 2005;50(4):411-420. PMID 15748694

Seger EW, Jauregui JJ, Horton SA, et al.(2017) Low-intensity pulsed ultrasound for nonoperative treatment of scaphoid nonunions: a meta-analysis. Hand (N Y). Apr 01 2017:1558944717702470. PMID 28391752

Song MH, Kim TJ, Kang SH, et al.(2019) Low-intensity pulsed ultrasound enhances callus consolidation in distraction osteogenesis of the tibia by the technique of lengthening over the nail procedure. BMC Musculoskelet Disord. Mar 14 2019; 20(1): 108. PMID 30871538

Strauss E, Ryaby JP, McCabe J.(1999) Treatment of Jones’ fractures of the foot with adjunctive use of low-pulsed ultrasound stimulation [abstract]. J Orthop Trauma. 1999;13(4):310. PMID

Tarride JE, Hopkins RB, Blackhouse G, et al.(2017) Low-intensity pulsed ultrasound for treatment of tibial fractures: an economic evaluation of the TRUST study. Bone Joint J. Nov 2017;99-B(11):1526-1532. PMID 29092994

Tsumaki N, Kakiuchi M, Sasaki J, et al.(2004) Low-intensity pulsed ultrasound accelerates maturation of callus in patients treated with opening-wedge high tibial osteotomy by hemicallotasis. J Bone Joint Surg Am. Nov 2004;86-A(11):2399-2405. PMID 15523009

Ultrasound stimulation for nonunion fracture healing. Decision memorandum. Quality site page. Quality care. Coverage process. http://www.hcfa.gov/quality/8b3-bb2.htm. Accessed September 14 2000.

Urita A, Iwasaki N, Kondo M et al.(2013) Effect of low-intensity pulsed ultrasound on bone healing at osteotomy sites after forearm bone shortening. J Hand Surg Am 2013; 38(3):498-503.

Warden SJ, Bennell KL, McMeeken JM, et al.(2000) Acceleration of fresh fracture repair using the Sonic Accelerated Fracture Healing System (SAHFS): a review. Calcif Tissue Int 2000; 66:157-163.

Wu AM, Bisignano C, James SL, et al.(2021) Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. Sep 2021; 2(9): e580-e592. PMID 34723233

Zura R, Della Rocca GJ, Mehta S, et al.(2015) Treatment of chronic (>1 year) fracture nonunion: heal rate in a cohort of 767 patients treated with low-intensity pulsed ultrasound (LIPUS). Injury. Oct 015;46(10):2036-2041. PMID 26052056
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