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Kyphon

Manufactured by Medtronic
Sourced in Ireland

The Kyphon is a medical device that is used for the treatment of vertebral compression fractures. It is designed to restore the height of the vertebral body and stabilize the fracture.

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7 protocols using kyphon

1

Kyphoplasty Cement Phantom Dosimetry

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A PMMA phantom (Kyphon, Medtronic) was created at our institutional instrument shop. Megavolt beam attenuation as it passed through a kyphoplasty cement phantom was measured. The electron density of the cement in a CT scan of the phantom was adjusted such that the computed attenuation matched the measured attenuation. The corrected electron density values were then substituted into the treatment planning system (Eclipse, Varian Medical Systems) for a number of patients who had received kyphoplasty procedures prior to radiation therapy. Dose to the cord and PTV were recalculated and compared with uncorrected values.
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2

Balloon Kyphoplasty for Vertebral Augmentation

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BKP, which has been previously described (15 (link)), was performed at all treated vertebral levels. In brief, a bone tamp was inserted into the vertebral body under fluoroscopic guidance, the inner stylet removed leaving the trocar, and a kyphoplasty balloon inserted through the trocar (Kyphon; Medtronic, Dublin, Ireland). The balloon was inflated with radiocontrast medium, which allows for visualization, compacts cancellous bone, and re-expands the vertebral body. Last, the balloon was deflated and removed, and PMMA from the Kyphon kit was injected through the trocar under fluoroscopic guidance. The method of vertebral body access was recorded for BKP at 160 levels. A unipedicular approach was used at 111 (69.4%) vertebral levels, and a bipedicular approach at 49 (39.6%) vertebral levels. Fluoroscopy time was recorded during 96 procedures for treatment of 137 vertebral levels, and mean time was 10.2 ± 5.9 minutes per procedure or 8.3 ± 4.1 minutes per vertebral level.
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3

Balloon Kyphoplasty for Vertebral Augmentation

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BKP, which has been previously described (15 (link)), was performed at all treated vertebral levels. In brief, a bone tamp was inserted into the vertebral body under fluoroscopic guidance, the inner stylet removed leaving the trocar, and a kyphoplasty balloon inserted through the trocar (Kyphon; Medtronic, Dublin, Ireland). The balloon was inflated with radiocontrast medium, which allows for visualization, compacts cancellous bone, and re-expands the vertebral body. Last, the balloon was deflated and removed, and PMMA from the Kyphon kit was injected through the trocar under fluoroscopic guidance. The method of vertebral body access was recorded for BKP at 160 levels. A unipedicular approach was used at 111 (69.4%) vertebral levels, and a bipedicular approach at 49 (39.6%) vertebral levels. Fluoroscopy time was recorded during 96 procedures for treatment of 137 vertebral levels, and mean time was 10.2 ± 5.9 minutes per procedure or 8.3 ± 4.1 minutes per vertebral level.
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4

Vertebral Fracture Treatment Comparison

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Two spines of two Caucasian females (73 and 81 years of age) were used (Source: Anatomy Gifts Registry, Hanover, MD, USA). The DXA-score confirmed osteoporosis (T-scores − 2.4 and − 3.7 respectively). The vertebral bodies from T8 to L4 were dissected and freed from surrounding tissues. Vertebral bodies with fractures and the corresponding vertebral body in the other spine were excluded. Standardized vertebral wedge compression fractures were created by a material testing machine (Instron® 5566) using an previously established fracture model [9 (link)]. In order to reduce the anterior height of the vertebral body an axial load was continuously increased until 30% of the initial height of the anterior endplate was reached. Compression force was maintained for 15 minutes. After the fracture two groups were randomly assigned in a matched pair design: 8 vertebral bodies (VB) were treated with balloon kyphoplasty (Kyphon, Medtronic) and 8 vertebral bodies by Tektona® (Spineart, Switzerland). CT-scans were taken before and after fracture, as well as after treatment.
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5

Bisegmental POS with Kyphoplasty

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All patients underwent bisegmental POS in prone position under general anesthesia. Surgery was performed by or under the supervision of an experienced spine surgeon. Using a typical minimal invasive approach, four polyaxial pedicle screws (Longitude, Medtronic, Memphis, TN, USA) were implanted under fluoroscopic guidance. Indirect reduction of the fractured vertebra via ligamentotaxis was performed.
In the study group direct reduction was performed by percutaneous bipedicular BK of the fractured vertebra. The balloon (Kyphon®, Medtronic, Memphis, TN, USA) was slowly inflated and endplate reduction performed under X-ray control. The balloon was then removed and bone cement was applied corresponding to the volume of the vertebra as well as to the degree of destruction. The volume of injected calcium phosphate cement averaged 5,5 ml (range, 3–6 ml) per vertebra. Decision for the use of additional kyphoplasty was based on the surgeon’s preference.
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6

Kyphoplasty for Vertebral Fracture Pain

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Kyphoplasty was performed in cases wherein conservative treatment failed to alleviate the pain in 6 weeks after the appearance of the symptoms. The kyphoplasty technique was chosen according to the spine surgeon’s choice, without any specific preference for a particular procedure. Each procedure was performed after obtaining written informed consent from the patient. Patients were positioned in the prone position. Closed reduction before the procedure was attempted by using displaceable positioning pillows or flexible surgical tables. A bipedicular surgical approach was performed for BKP using the KYPHON (Medtronic plc, Dublin, Leinster, Ireland) or SYNFLATE (Depuy Synthes, West Chester, PA, USA) system. In contrast to BKP, a unipedicular approach was used for RFK with the StabiliT system (DFine, San Jose, CA, USA).
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7

Stepwise Kyphoplasty and Vertebral Augmentation

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The surgical procedures were performed with the patients in prone position on a
radiolucent carbon operating table. Firstly, balloon kyphoplasty (Kyphon,
Medtronic ) and injection of CPC (Kyphos, Medtronic) were performed. To
attribute the strong pediatric bone, kyphoplasty was realized very carefully
raising the pressure stepwise (50 pounds per square inch [PSI] increments to a
final pressure of 250-300 PSI) and pausing until the pressure declined to a
stable value. Repeated intra-operative x-rays confirmed adequate reduction of
the fractured vertebra. The void was then augmented with CPC under image
intensifier control. No cement leakage was detected. Thereafter, dorsal
percutaneous instrumentation of the adjacent segments using the Medtronic
Longitude system (Medtronic) was performed. The fascia was carefully closed to
avoid subcutaneous hematoma. Postoperatively, the patients had bed rest for 24 h
according to the choice of the surgeons followed by mobilization with full
weight bearing and without brace. Sports activities were prohibited for 3
months.
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