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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

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.

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

Denna studie visade att EXOGEN kan vara användbar i behandling av utmanande, etablerade oläkta frakturer, med en generell läkningsgrad på 86 %.

Komplett artikel tillgänglig på PubMed.gov.

Low-intensity pulsed ultrasound: effects on nonunions.

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

I denna studie behandlades 67 oläkta frakturer med EXOGEN. Efter dagliga 20-minutersbehandlingar var 85 % av de oläkta fallen läkta.

Komplett artikel tillgänglig på 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

I den första nivå I-studien om läkningstakt för oläkta frakturer behandlades 51 patienter med fördröjda tibialläkningar med EXOGEN. Genomsnittlig ökning av mineraldensiteten i deras ben var 1,34 gånger högre än hos patienterna som fick behandling med den falska enheten.

Komplett artikel tillgänglig för Nedladdning eller på 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

Denna studie visar att rökare med indikerade* tibial- och radiusfrakturer läker snabbare när de använder EXOGEN — 41 % snabbare för tibiafrakturer och 51 % snabbare för distala radiusfrakturer.

Komplett artikel tillgänglig på 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

Denna studie demonstrerar effektiviteten hos EXOGEN-benläkningssystemet. Läkningstid för nya* frakturer visade sig påskyndas signifikant när EXOGEN användes 20 minuter per dag. 94 % av frakturerna i EXOGEN-gruppen var läkta efter 150 dagar.

Komplett artikel tillgänglig på PubMed.gov.

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 denna studiex använde 60 patienter med nya radiusfrakturer antingen EXOGEN eller en placeboenhet i 10 veckor. EXOGEN-användare hade en betydligt kortare tid till läkning, med ökad takt påvisad vid varje läkningsstadium.

Komplett artikel tillgänglig på 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.

Denna pilotserie hade för avsikt att utvärdera användning av EXOGEN vid behandling av oläkta lårbens- eller tibiafrakturer. Den 88-procentiga benläkningsgraden, som är högre än i traditionell kirurgi och som har en enhetskostnad som är minst 60 % lägre, stödjer förespråkande förstahandsimplementering vid oläkta frakturer som är mindre än 10 mm med stabil benbildning.

Abstract tillgängligt på PubMed.gov.

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