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A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): findings in the elderly versus all patients.

BMC Musculoskeletal Disorders,
Robert Zura, Samir Mehta, Gregory J. Della Rocca, John Jones, R. Grant Steen


Patient age is one of many potential risk factors for fracture nonunion. Our hypothesis is that older patients (≥ 60) with fracture risk factors treated with low-intensity pulsed ultrasound (LIPUS) have similar heal rate (HR) to the population as a whole. We evaluate the impact of age in conjunction with other risk factors on HR in LIPUS-treated patients with fresh fracture (≤ 90 days old).


The Exogen Bone Healing System is a LIPUS device approved in 1994 to accelerate healing of fresh fracture. After approval, the FDA required a Post-Market Registry to assess performance. Patient data collected from October 1994 until October 1998 were individually reviewed and validated by a registered nurse. Four distinct data elements were required to report a patient: date fracture occurred; date treatment began; date treatment ended; and a dichotomous outcome of healed v. failed, by clinical and radiological criteria. Data were used to calculate two derived variables; days to treatment (DTT) and days on treatment (DOT). Every validated fresh fracture patient with DTT, DOT, and outcome is reported.


The validated registry had 5,765 patients with fresh fracture; 73% (N = 4,190) are reported, while 13% of patients were lost to follow-up, 11% withdrew or were non-compliant, and 3% died or are missing outcome. Among treatment-compliant patients, HR was 96.2%. Logistic estimates of the odds ratio for healing are equivalent for patients age 30 to 79 years and all age cohorts had a HR > 94%. Open fracture, current smoking, diabetes, vascular insufficiency, osteoporosis, cancer, rheumatoid arthritis, and prescription NSAIDs all reduced HR, but older patients (≥ 60) had similar HRs to the population as a whole. DTT was significantly shorter for patients who healed (p < 0.0001).


Comorbid conditions in conjunction with aging can reduce fracture HR. Patients with fracture who used LIPUS had a 96% HR, whereas the expected HR averages 93%. Time to treatment was significantly shorter among patients who healed (p < 0.0001), suggesting that it is beneficial to begin LIPUS treatment early. Older patients (≥ 60) with fracture risk factors treated with LIPUS exhibit similar heal rates to the population as a whole.


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Low-Intensity Pulsed Ultrasound for Treatment of Fractures and Nonunions - Current Evidence and Insights from Basic Research and Clinical Application

Z Orthop Unfall.,
Randau TM, Kabir K, Gravius S, Wimmer MD, Friedrich MJ, Burger C, Goost H

In Germany, 800,000 fractures are treated per year, and up to 10 % of these patients may suffer subsequently from a delayed union or a nonunion at the fracture site. Surgical treatment of these complications is tedious and associated with high costs. Therefore non-operative treatment is recently receiving more scientific and clinical attention. The adjuvant treatment with ultrasound has been propagated for the past years to enhance fracture healing and bony union, and has been discussed controversially. This review article demonstrates the significance of the low intensity pulsed ultrasound application in fracture treatment, on the basis of basic science results, animal experiments and the results of clinical trials.

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Low-intensity pulsed ultrasound in the treatment of nonunions.

The Journal of Trauma,
Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH

Denne studien påviste at EXOGEN kan være nyttig i behandling av utfordrende, etablerte manglende tilhelinger, med en total tilhelingsrate på 86 %.

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Low-intensity pulsed ultrasound: effects on nonunions

Ultrasound in Medicine and Biology,
Gebauer D, Mayr E, Orthner E, Ryaby JP

I denne studien ble67 frakturer med manglende tilheling behandlet med EXOGEN. Etter daglige 20-minutters behandlinger var 85 % av tilfellene med manglende tilheling tilhelt.

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Acceleration of tibia and distal radius fracture healing in patients who smoke

Clinical Orthopaedics and Related Research,
Cook SD, Ryaby JP, McCabe J, Frey JJ, Heckman JD, Kristiansen TK

Denne studien påviste at røykere med indiserte* tibia- og radiusfrakturer heles raskere ved bruk av EXOGEN – 41 % raskere for tibiafrakturer og 51 % raskere for distale radiusfrakturer.

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Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound.

The Journal of Bone and Joint Surgery,
Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF

Denne studien utviser effekten til EXOGEN-bentilhelingssystemet. Tilhelingstiden for nye* frakturer ble påvist å være betydelig akselerert når EXOGEN ble benyttet i 20 minutter hver dag, med 94 % av frakturene i EXOGEN-gruppen tilhelt etter 150 dager.

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Indications and results for the EXOGEN ultrasound system in the management of non-union: a 59-case pilot study.

Orthopaedics, Traumatology, Surgery & Research (OTSR),
Roussignol X, Currey C, Duparc F, Dujardin F.

Denne testserien hadde som mål å evaluere bruken av EXOGEN i behandling av manglende tilheling i femur eller tibia. Bentilhelingsraten på 88 %, som er høyere enn ved tradisjonell kirurgi og med minst 60 % lavere enhetskostnad, støtter anbefaling av førstelinjeinnføring ved manglende tilheling i områder under 10 mm med stabil osteosyntese.

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Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study.

The Journal of Bone and Joint Surgery,
Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR

I denne studien bruktex 60 pasienter med nye radiusfrakturer enten EXOGEN eller en placeboenhet i 10 uker. EXOGEN-brukere opplevde betydelig kortere tid til tilheling, med akselerasjon påvist i hvert stadium av tilhelingen.

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