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October 15, 2010

 

 

 

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Ultrasound 'Boosts Fracture Healing'

Study: Molecular Breast Imaging May be Useful in PASH Diagnosis

Improving Sonography Requires Improving Sonography School Admissions


Ultrasound 'Boosts Fracture Healing'

An ultrasound device “helps bones heal faster and stronger,” reported The Daily Telegraph.
The news is based on a trial that investigated whether a device emitting low-intensity pulsed ultrasound (LIPUS) could improve bone repair in patients whose shin bone fractures had healed slowly during the four months since their injury.

The trial gave 101 slow-healing patients either a genuine LIPUS treatment or an inactive sham treatment over 16 weeks. The LIPUS device was found to increase bone mineral density by 34% more than the sham device, and 65% of the LIPUS-treatment group were considered by a doctor to be healed compared to 46% of the sham-treatment participants.

While there was a drop-out rate of around 10%, the use of the device looks promising as it is a non-invasive treatment and no side effects were reported. Overall, this preliminary trial suggests that the treatment may be of some benefit to patients with delayed fracture healing.
The study was carried out by researchers from University Hospital Marburg and the University of Ulm in Germany. It was funded by Smith and Nephew, the manufacturers of the device used in this study. The study was published in the reviewed medical journal BMC Musculoskeletal Disorders. The research was well reported by The Daily Telegraph.

This was a randomized controlled trial that assessed whether low-intensity pulsed ultra sound (LIPUS) would increase bone healing compared with a sham treatment. The researchers were interested in whether the treatment would help people who had shown a slow rate of healing four months after their injury.

The researchers say that LIPUS has been shown to enhance healing in fresh fractures, and that some non-controlled trials suggest that LIPUS may help promote healing in older fractures that have failed to heal. However, they said no randomized controlled trial has been carried out among patients who had delayed fracture healing.

The manufacturers of the device suggest that the LIPUS device can perform several different roles in bone healing. They say that immediately after a break it can remove debris and bacteria from the site of the wound, while in later healing stages it can stimulate the bone marrow to produce immature bone cells and cartilage cells. The manufacturers say that during latter-stage healing (the period examine in this study), the device stimulates the membrane around the bone to seal. This allowed immature bone cells to collect and grow.

The research was carried out in six hospitals in Germany. The study recruited adults who had a fracture to their tibia (shin bone) but had displayed inadequate healing at least 16 weeks after their injury. The study did not include patients who were pregnant, had infected wounds, had excessive malalignment of their bone following the fracture, or had received an operation at the fracture site within 16 weeks of enrolment.

In total, 101 subjects between 14 and 70 years old were recruited and randomly allocated to treatment with either the active LIPUS device (51 people) or an inactive ‘sham’ LIPUS device (50 people). The device was the Exogen 2000/2000+, which is manufactured by Smith and Nephew in Germany.

The participants were instructed to use the device for 20 minutes a day for 16 weeks. All of the devices recorded the usage time per day as a means of assessing whether the participants were complying with the study protocol.

Computed tomography (CT) scanning was used to assess bone mineral density (BMD) and the gap at the fracture site. BMD was assessed at three regions of interest: the fracture site, 2-3 mm either side of the fracture site, and a healthy reference area. These measurements were taken before treatment and after the 16-week treatment course. Radiographs were also taken at one, two and three months. These were shown to doctors who judged the healing status (healed/not healed) of each subject.

Out of 101 participants who started the study, 84 completed it. Twelve out of the 50 participants who received sham treatment dropped out (24%), and five out of 51 of the LIPUS treated patients dropped out (9.8%). Overall, compliance with the treatment regimen was good. The median total time of device usage was 2,040 minutes out of a possible 2,240 minutes (91%).

In their statistical analysis the researchers took into account the potential bias of patients who had dropped out. The improvement in BMD was 1.34 (90% CI, 1.14 to 1.57) times greater for LIPUS-treated participants compared with the sham controls (p=0.002). The LIPUS-treated participants also had a greater reduction in the gap between their bone at the fracture site compared to the controls over the 16-week period (p=0.014).

At completion of the 16-week treatment period, 65% of LIPUS and 46% of sham-treated participants were considered by a doctor to be healed (p=0.07). The LIPUS device did not cause any side effects.

The researchers said that under normal clinical circumstances, approximately 4.4% of patients with shin bone fractures will have delays in bone healing. Surgery and bone grafts may be necessary in these patients. The researchers said that their research has extended the positive findings that LIPUS treatment can help healing in fresh fractures by showing that it benefits patients whose fractures have taken longer to heal.

This was a well-conducted randomized controlled trial, which showed that use of LIPUS improved the healing process by 34% compared to a control treatment.

As the device was used by the patients at home, a good aspect of the study design was that it recorded the amount of time patients used the device to assess whether they followed the study protocol. However, compliance with the device and adherence to the treatment instructions may be different when used by patients outside of the study setting. Also, 16% of the participants dropped out of the study, and their reasons for dropping out were not presented.

As more patients had dropped out of the sham control group than the LIPUS group, the researchers used statistical modeling to adjust for potential bias this may have caused to their results. However, details of how this was done were not explicit.

Overall, this preliminary study suggests that this non-invasive treatment appears to be of some benefit to patients who have delayed fracture healing.

View the article online

Article written by staff at nhs.com and adapted for the purposes of this newsletter.

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Study: Molecular Breast Imaging May be Useful in PASH Diagnosis

Molecular breast imaging (MBI) can play a useful role in the diagnosis of pseudoangiomatous stromal hyperplasia (PASH), in the presence of negative mammography and ultrasound images, according to a case study published in the July issue of the Journal of Surgical Radiology.

MBI, a novel nuclear medicine imaging technique used to image breast lesions, can detect technetium 99m (Tc99m) sestamibi uptake using dual-head Cadmium-Zinc-Telluride semiconductor detectors. Tc99m sestamibi is injected intravenously and is taken up by breast tumors.  

Pseudoangiomatous stromal hyperplasia (PASH) is a benign condition of the breast that frequently presents as a palpable mass. In this case of PASH, Deborah J. Rhodes, MD, assistant professor of medicine at the department of internal medicine at Mayo Clinic in Rochester, Minn., and colleagues demonstrated that MBI was critical in the diagnosis of PASH.

The case was a 35-year old woman with a palpable abnormality in the right breast found on routine clinical examination. At age 16, she was treated for left breast rhabdomyosarcoma with mastectomy, implant reconstruction, adjuvant chemotherapy and radiation to the left chest wall, supraclavicular lymph nodes and axillary lymph nodes. She subsequently underwent right breast reduction twice, according to Rhodes and colleagues. 

Physical examination revealed a palpable thickening at the 10 o’clock position of the right breast. Mammography showed no abnormalities and focused ultrasound of the area revealed normal breast parenchyma and no focal masses. The patient continued with clinical observation, and repeat screening mammogram one year later also showed no areas of concern, wrote Rhodes and colleagues. 

The patient underwent MBI with 20mCi Tc99m sestamibi. MBI revealed a 2.3 x 2.2 cm focus of uptake in right upper outer quadrant of the breast. As a result of the MBI, diagnostic mammography and repeat ultrasound were completed for additional imaging by Rhodes and colleagues. Spot compression magnification views of the right breast upper outer quadrant revealed a 2 cm vague focal asymmetry with partial effacement. Ultrasound of this area revealed no focal masses. MRI demonstrated a segmental area of clumped, persistent enhancement measuring 4.1 x 2.5 x 2.0 cm. “MRI-guided biopsy revealed PASH,” noted Rhodes and colleagues.  

Pathology revealed florid PASH forming an ill-defined mass in the upper outer quadrant measuring 3.6 x 2.5 x 2.3 cm when the patient elected to undergo nipple sparing mastectomy with immediate reconstruction one year later.

“This is the first report of MBI findings of PASH. PASH does demonstrate uptake of Tc99m,” reported Rhodes and colleagues. MBI can be useful in problem solving, particularly in the workup of questionable palpable lesions when initial imaging studies are negative on mammography and ultrasound, they offered.

“In this case of PASH, MBI detected focal uptake of Tc99m. When focal uptake is seen on MBI and biopsy reveals PASH, these findings can be concordant and may not necessarily require excision. Radiologic and pathologic correlation remains important,” concluded Rhodes and colleagues.

View the article online

Article written by staff at healthimaging.com and adapted for the purposes of this newsletter.

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Improving Sonography Requires Improving Sonography School Admissions

Diagnostic ultrasounds are the most widely used medical tests in the world. Though the technology is more than 50 years old, scientists continue to discover new uses for it, ranging from more targeted cancer treatments to liposuction. As the technology becomes more complex, a sonographer’s skill level is even more important. Now, researchers at the University of Missouri may have found one of the keys to becoming a successful sonographer: spatial ability.

Doug Clem, clinical assistant professor of MU’s diagnostic ultrasound program in the MU School of Health Professions, led the study of ultrasound students’ spatial abilities. The study is the first to show how students’ spatial abilities correlated to their results on scanning proficiency tests. Spatial ability is the ability to process and understand physical relationships among objects. This is important in sonography because ultrasounds are not like other medical tests, such as x-rays or CT scans. A sonographer cannot capture the entire object at once, but instead must collect a series of images and assemble them into a logical sequential order for a physician to read.

“It’s operator dependent,” said Sharlette Anderson, clinical instructor of MU’s diagnostic ultrasound program. “I can scan the entire liver, but I’m not giving the radiologist images of every millimeter of the liver. I am giving him specific images and anything that I see that looks abnormal. If I miss an abnormality, the radiologist never sees it and the diagnosis is missed.”

The study tested first-year ultrasound students’ spatial abilities prior to any major coursework. Then, scientists tracked students’ results on standard scanning proficiency tests over two semesters. Initially, the study showed little association between spatial ability and scanning proficiency. However, by the end of the academic year, students with greater spatial abilities were much more likely to have scored high on scanning tests.

Clem sees spatial ability tests as a potential consideration for admission to a sonography program. Currently, the program uses academic criteria like grade point average and ACT scores to evaluate undergraduate applications. Other professions, including dentistry and engineering, have used spatial ability testing for years. Spatial ability is affected by genetics, but recent research has shown that individuals can improve their spatial ability. Participating in certain hobbies, such as playing video games, working puzzles and other similar activities can encourage spatial ability development.

“Even though you may be a really strong academic student, you may not learn to scan as easily as other people might.” Clem says. “Some of our best students, straight-A students, will need extra time or extra clinical time to get past their scanning competency tests. This poses a challenge for selecting the best candidates for admission, and we think that spatial ability testing may turn out be one more piece of the puzzle that is needed to select the right individual.”

The study was published in the Journal of Diagnostic Medical Sonography. Clem worked with Anderson and Moses Hdeib, director of the diagnostic ultrasound program. The team has started a second study, in cooperation with several universities, community colleges and proprietary schools from across the country. Through this larger study, Clem hopes to further validate the results of the first study by increasing the number of students observed. Depending on the results of the second study, the department will consider changing admission requirements next summer.

View the article online

Article written by staff at healthnewsdiget.com and adapted for the purposes of this newsletter.

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NewsWire. Copyright 2010.  American Registry for Diagnostic Medical Sonography. The ideas and opinions expressed herein do not necessarily reflect those of ARDMS.

 

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