Low intensity pulsed ultrasonography for fractures: Systematic review of randomised controlled trials

Institute for Work and Health, Toronto, Canada.
BMJ (online) (Impact Factor: 17.45). 02/2009; 338(feb27 1):b351. DOI: 10.1136/bmj.b351
Source: PubMed


To determine the efficacy of low intensity pulsed ultrasonography for healing of fractures.
Systematic review of randomised controlled trials.
Electronic literature search without language restrictions of CINAHL, Embase, Medline, HealthSTAR, and the Cochrane Central Registry of Controlled Trials, from inception of the database to 10 September 2008. Review methods Eligible studies 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.
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.

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Available from: Jason W Busse
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    • "Although a number of randomized trials have suggested that LIPUS may improve fracture healing, inferences are limited because of small sample size, risk of bias, frequent reporting of surrogate outcomes (such as radiographic healing) but limited attention to patient-important outcomes (functional recovery), and inconsistent results [9]. Until a large randomized controlled trial (RCT) is undertaken, the effect of LIPUS on fracture healing will remain uncertain. "
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    ABSTRACT: The role of low-intensity pulsed ultrasound (LIPUS) in the management of fractures remains controversial. The purpose of this study was to assess the feasibility of a definitive trial to determine the effect of LIPUS on functional and clinical outcomes in tibial fractures managed operatively. We conducted a multicenter, concealed, blinded randomized trial of 51 skeletally mature adults with operatively managed tibial fractures who were treated with either LIPUS or a sham device. All participating centers were located in Canada and site investigators were orthopedic surgeons specializing in trauma surgery. The goals of our pilot study were to determine recruitment rates in individual centers, investigators’ ability to adhere to study protocol and data collection procedures, our ability to achieve close to 100% follow-up rates, and the degree to which patients were compliant with treatment. Patients were followed for one year and a committee (blinded to allocation) adjudicated all outcomes. The committee adjudicators were experienced (10 or more years in practice) orthopedic surgeons with formal research training, specializing in trauma surgery. Our overall rate of recruitment was approximately 0.8 patients per center per month and site investigators successfully adhered to the study protocol and procedures. Our rate of follow-up at one year was 84%. Patient compliance, measured by an internal timer in the study devices, revealed that 39 (76%) of the patients were fully compliant and 12 (24%) demonstrated a greater than 50% compliance. Based on patient feedback regarding excessive questionnaire burden, we conducted an analysis using data from another tibial fracture trial that revealed the Short Musculoskeletal Function Assessment (SMFA) dysfunction index offered no important advantages over the SF-36 Physical Component Summary (PCS) score. No device-related adverse events were reported. Our pilot study identified key issues that might have rendered a definitive trial unfeasible. By modifying our protocol to address these challenges we have enhanced the feasibility of a definitive trial to explore the effect of LIPUS on tibial fracture healing. Trial registration The TRUST definitive trial was registered at on 21 April 2008 (identifier: NCT00667849).
    Full-text · Article · Jun 2014 · Trials
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    • "encourage bone union in the clavicle still needs to be validated [42] [43] [44]. "
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    ABSTRACT: Introduction The aim of our study was to evaluate the results of surgical treatment of clavicle non-union after failure of conservative treatment. Our hypothesis was that stable fixation with bone graft derived from local bone stock (fracture site) or the iliac crest was essential to achieve bone union. Material and methods Twenty-one patients with a symptomatic middle-third clavicle non-union after failure of initial conservative treatment were included in the study. Delay between the initial fracture and surgery for non-union was 27 months (6–144). In five cases, the non-union was hypertrophic and bone graft was obtained locally from the callus. In 16 patients, the non-union was atrophic. Bone was harvested from the iliac crest as cortico-cancellous graft (7 patients) and cancellous graft (8 patients). One patient refused bone grafting. A 3.5-mm plate with non-locking screws was placed anterior in 12 and superior in 9 patients. Results At 41 months average follow-up (minimum of 12 months), 20 patients were available for review. Bone healing was obtained initially in 15 cases. Six complications required a revision procedure: 3 for infection and 3 for mechanical failure. At last follow-up, 19 patients were satisfied with the surgery. Average Constant score was 84 ± 26 points (7–100), and Quick DASH score 17 ± 22 points (0–91). Radiographic bone healing was obtained in 19 of the cases. Conclusion Treatment of middle-third clavicle non-union after initial failure of conservative treatment with stable fixation and bone graft is a reliable, well-suited and effective treatment. Our hypothesis was verified. Preoperative evaluation of appearance of the non-union X-rays can be used to determine the type of bone graft needed, but the final decision is often taken during surgery. Level of evidence Level IV.
    Full-text · Article · Apr 2014 · Orthopaedics & Traumatology Surgery & Research
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    • "Basic research, including in vitro [7] and animal studies [8–10], has shown that LIPUS accelerates the repair reactions involved in bone union at the cellular level. Busse [11] published a systematic review of clinical studies on LIPUS therapy in 2009. In conservatively treated fresh fractures, an analysis of 67 cases of diaphyseal fracture of the tibia [12], 61 cases of distal radius fracture [13], and 30 cases of scaphoid fracture [14] found LIPUS therapy to be effective. "
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    ABSTRACT: Background There are no evidence on the effects of low-intensity pulsed ultrasound (LIPUS) on surgically managed fresh fractures. We therefore performed a multicenter retrospective cohort study to investigate the effects of LIPUS on surgically managed fresh fractures. Methods This study included patients surgically treated for diaphyseal fractures of the femur or tibia between August 2009 and July 2010 at 14 institutions. Outcome was the union period. We performed an overall comparison of the LIPUS group (78 cases) with the control group (63 cases), as well as subgroup analyses comparing outcomes for fracture sites, fracture types, soft tissue conditions, and fixation methods between the groups. Results There was no significant difference between the groups in terms of distribution of cases by fracture site, fracture type, soft tissue condition, fixation method. Analyses comparing subgroups, however, showed significant differences between the two groups, particularly in relation to type C fractures, regardless of whether all cases or only closed-fracture cases were analyzed: there was an approximately 30 % reduction in the union period for type C fractures in the LIPUS group. There were also cases requiring reoperation due to lack of stability, even among the type C fractures. Conclusions LIPUS is effective for surgically managed, fresh, type C comminuted diaphyseal fractures of the lower limbs when there is appropriate stability at the fracture site.
    Preview · Article · Mar 2013 · Journal of Orthopaedic Science
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