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Journal Articles

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

BACKGROUND:

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).

METHODS:

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.

RESULTS:

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).

CONCLUSIONS:

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.

 

Full article available at PubMed.gov.

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.

Full article available at PubMed.gov.

Improved Healing Response in Delayed Unions of the Tibia with Low-Intensity Pulsed Ultrasound: Results of a Randomized Sham-Controlled Trial

BMC Musculoskeletal Disorders,
Schofer MD, Block JE, Aigner J, Schmelz A

In the first Level-I study regarding non-union† heal rates, 51 patients with tibia delayed unions were treated with EXOGEN. Mean improvement in their bone mineral density was 1.34 times greater than that of patients who received sham device treatment.

Full article available at download or at PubMed.gov.

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

This study found that EXOGEN can be useful in the treatment of challenging, established non-unions, with an 86% overall healing rate.

Full article available at PubMed.gov.

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

This study demonstrates the efficacy of the EXOGEN bone healing system. Healing time for fresh* fractures was found to be significantly accelerated when EXOGEN was applied for 20 minutes a day, with 94% of the fractures in the EXOGEN group healed after 150 days.

Full article available at PubMed.gov.

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

This study finds that smokers with indicated* tibia and radius fractures heal faster when using EXOGEN—41% faster for tibia fractures and 51% faster for distal radius fractures.

Full article available at PubMed.gov.

Cost-Effectiveness of Bone Stimulators in the Conservative Treatment of Stable Non-Union Fractures

International Society for Pharmacoeconomics and Outcomes Research, Seventh Annual European Congress, Hamburg, Germany,
Schultz M, Oremus M, Whitman CS, Conway JD

This white paper evaluates the expected cost of treating a non-union† fracture using five fracture stimulation devices. Researchers determine that EXOGEN is the most cost-effective treatment and is optimal for 85% of patients.

Download white paper.

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

In this studyx 60 patients with fresh radius fractures used either EXOGEN or a placebo device for 10 weeks. EXOGEN users had a significantly shorter time to union, with acceleration demonstrated at every stage of healing.

Full article available at PubMed.gov.

The economics of treating tibia fractures. The cost of delayed unions.

Published in the Bulletin for NYU Hospital for Joint Diseases,
Heckman JD, Sarasohn-Kahn J

In this study,researchers compare three economic models for treating a pool of 1,000 patients with tibia fractures. Using EXOGEN in conservative and operative treatment paths resulted in an overall savings of $14.6 million—a reduction in cost that would benefit third-party payers, employers, government agencies and patients. p>

Full article available at PubMed.gov.

Low-intensity pulsed ultrasound: effects on nonunions.

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

In this study, 67 non-union fractures were treated with EXOGEN. After daily 20-minute treatments, 85% of the non-union cases were healed.

Full article available at PubMed.gov.

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.

This pilot series sought to assess the use of EXOGEN in the treatment of femoral or tibial non-unions. The 88% bone healing rate, which is higher than in traditional surgery and with a unit cost at least 60% lower, supports advocating first-line implementation in non-unions of less than 10mm with stable osteosynthesis.

Abstract available at PubMed.gov.

  • High treatment
    compliance21
  • +
  • Proven clinical
    effectiveness2-4
  • > >
  • Successful fracture
    healing outcomes