http://www.healio.com/orthopedics/journals/ortho/%7Bb4efa19a-ad69-4185-b719-8f6ab826332f%7D/ct-characterizing-the-anatomy-of-uninjured-ankle-syndesmosis#

CT Characterizing the Anatomy of Uninjured Ankle Syndesmosis

Elliot S. Mendelsohn, MD; C. Max Hoshino, MD; Thomas G. Harris, MD; Daniel M. Zinar, MD

Abstract

Although it is expert opinion that transsyndesmotic screws are placed obliquely 30° from posterolateral to anteromedial in the transverse plane, this has not been formally studied, and there is inconsistency regarding the congruency of the distal tibiofibular joint. Thirty-eight computed tomography (CT) scans of the lower extremity were used to examine the rotational profile of the axis of the syndesmotic joint in relation to the femoral transepicondylar axis and to describe the congruency of this joint. The axis of the distal tibiofibular joint was 32°±6° externally rotated in relation to the transepicondylar axis. The average anterior, central, and posterior widths of the syndesmotic joint space 10 mm superior to the joint line were statistically significantly different: 1.7±0.9 mm, 1.7±0.6 mm, and 2.3±1.1 mm, respectively (P=.004). This study demonstrates that the axis of the uninjured distal tibiofibular joint is approximately 30° externally rotated in relation to the transepicondylar axis. Therefore, reduction clamps and screws should be placed at this angle to avoid malreduction of the syndesmosis. The posterior joint space width is significantly wider than the anterior and central joint spaces. This study’s results provide a description of the anatomy of the uninjured distal tibiofibular joint to guide reduction maneuvers and establish a baseline for evaluation of postreduction CT scans.

The authors are from the Department of Orthopaedic Surgery, Harbor-UCLA Medical Center, Torrance, California.

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Elliot S. Mendelsohn, MD, Department of Orthopaedic Surgery, Harbor-UCLA Medical Center, 1000 W Carson St, Box 422, Torrance, CA 90509 ( elliotmendelsohn@yahoo.com).

Received: August 12, 2013

Accepted: September 05, 2013

Posted Online: February 07, 2014

A syndesmotic injury occurs in up to 13% of all ankle fractures1,2 and in 20% of patients requiring internal fixation.3,4 Closed reduction of the distal tibiofibular joint results in malreduction in 16% to 52% of patients.5,6 Patients with malreduction of the syndesmotic joint have inferior clinical outcomes compared with patients with an anatomic reduction.7

Although the restoration of anatomic alignment of the distal tibiofibular joint is both difficult to achieve and important for optimal clinical outcomes, little attention has been devoted to the anatomy of the uninjured syndesmotic joint.8–11 Although it is expert opinion that transsyndesmotic screws are placed obliquely 30° from posterolateral to anteromedial in the transverse plane, this has not been formally studied.12 In addition, the proper placement of reduction tenaculums is necessary to achieve an anatomic reduction. A recent study reported that reduction clamps must be placed perpendicular to the syndesmotic joint because clamps that are placed diagonally reproducibly result in malreduction.13 However, the study did not describe how to achieve or confirm perpendicular clamp placement. Moreover, inconsistency exists in the literature regarding the relative widths of the anterior and posterior portions of the uninjured distal tibiofibular joint.11,14

The 2 goals of this study were to describe the rotational profile of the syndesmotic joint with respect to the transepicondylar axis and to describe the congruency of the joint as determined by the varying joint space widths.

Materials and Methods

Prior to initiation of the study, institutional review board approval was obtained. All consecutive computed tomography (CT) angiograms of the lower extremity ordered by the Harbor-UCLA Vascular Service between July 1, 2010, and April 30, 2011, were included in the study. Most CT angiograms were performed to evaluate for chronic vascular disease in patients who had not sustained an acute injury. Each limb was scanned by taking anatomically true axial cuts; therefore, all images were parallel to the tibial plafond. Computed tomography scans had to include the distal femur through the ankle and be performed with thin cuts (1.5-mm-thick sections or less). All scans were obtained with a GE ProSpeed CT scanner (General Electric, Milwaukee, Wisconsin) using a bone algorithm. Contiguous 0.5- to 1.5-mm-thick sections from the mid-thigh through the ankle were examined using a high-resolution monitor. Each CT scan was reviewed for an acute or chronic osseous injury. If any injury was suspected, then that patient was excluded from the study. All measurements were performed using standard digital imaging calipers that were adjusted for variability in magnification.

Measuring the Rotational Profile of the Syndesmotic Joint

A line was drawn between the most prominent points of the lateral and medial femoral epicondyles to establish the transepicondylar axis (Figure 1). The rotation of the distal tibiofibular joint was established by drawing a perpendicular line bisecting the joint (Figure 2). The transepicondylar axis was superimposed on the axis of the syndesmotic joint, and the difference between the 2 was measured (Figure 3).

Figure 1: Cross-sectional computed tomography scan showing measurement of the transepicondylar axis.

Figure 2: Cross-sectional computed tomography scan showing measurement of the distal tibiofibular joint axis.

Figure 3: Drawing showing measurement of the angle between the syndesmotic joint axis and the transepicondylar axis.

Syndesmotic Joint Width Measurements

The width of the syndesmotic joint was measured 10 mm superior to the joint line. The anterior, central, and posterior widths were measured for comparison. First, the center of the joint was established and the width measured. Next, the most peripheral points of the joint anteriorly and posteriorly were marked. At the halfway point between the central mark and the most peripheral marks, the anterior and posterior joint spaces were measured. Therefore, the anterior measurement was taken at the junction of the anterior 2 quartiles and the posterior measurement at the junction of the posterior 2 quartiles (Figure 4).

Figure 4: Cross-sectional computed tomography scan showing measurement of the anterior, central, and posterior width of the distal tibiofibular joint 10 mm proximal to the tibiotalar joint.

Statistical Analysis

Student’s t test was used for comparison of the syndesmotic joint rotational profile between the right and left lower extremity in patients with bilateral imaging. Analysis of variance test was used to compare differences between the anterior, central, and posterior joint width.

Results

Demographic Characteristics

Forty-five consecutive thin-cut CT scans of the lower extremity met the inclusion criteria. Seven CT scans were excluded for 2 reasons: motion artifact (n=4) and bony injury to the lower extremity (n=3). There was 1 chronic tibia plateau fracture, 1 acute distal femur fracture, and 1 acute gunshot wound to the proximal tibia. In 17 patients, bilateral lower extremities were imaged, and in 4 patients, only 1 lower extremity was imaged, for a total of 38 studies. The study cohort comprised 16 men and 5 women with an average age of 51. There were 17 right lower extremity scans and 21 left lower extremity scans.

Syndesmotic Joint Rotational Profile

The axis of the syndesmotic joint was 32°±6° externally rotated in relation to the transepicondylar axis. In patients with bilateral CT scans, the axis of the syndesmotic joint was 30°±6° externally rotated in relation to the transepicondylar axis and was not statistically significantly different from the left lower extremity (30°±5°) (P=.9).

Syndesmotic Joint Space Width

Average anterior, central, and posterior widths of the syndesmotic joint space were statistically significantly different: 1.7±0.9 mm, 1.7±0.6 mm, and 2.3±1.1 mm, respectively (P=.004).

Discussion

The current study is the first to confirm that the distal tibiofibular joint axis is approximately 30° externally rotated in relation to the femoral transepicondylar axis. Understanding the normal rotation of the syndesmosis is important because tenaculums must be placed perpendicular to the syndesmosis to achieve an accurate reduction. When the clamp is placed obliquely to the joint, compressive forces are converted to sheer forces, resulting in fibular translation and/or rotation. If the clamp is placed in internal rotation, then the fibula translates posteriorly and/or internally rotates. The converse is true with an externally rotated clamp, producing anterior translation of the fibula and/or external rotation (Figure 5).13 Inaccurate clamp placement is probably the cause of the high incidence of syndesmotic joint malreduction when a closed reduction is attempted. Similarly, transsyndesmotic screws should be oriented approximately 30° externally rotated from the horizontal axis to avoid malreduction.

Figure 5: Drawing showing that internally rotated clamps produce posterior subluxation of the fibula, whereas externally rotated clamps produce anterior subluxation of the fibula.

The accuracy of reduction of the distal tibiofibular joint cannot be determined using plain radiographs.15 Therefore, CT scans are now frequently used to evaluate reduction of this joint. It is important to understand the anatomy of the uninjured syndesmotic joint to provide a baseline for postoperative evaluation. The current study found that the normal distal tibiofibular joint is significantly wider posteriorly than anteriorly. This is in agreement with the results of a study by Elgafy et al,11 which found that the average anterior and posterior joint space was 2 mm and 4 mm, respectively. Conversely, Pelton et al14 found the anterior and posterior width of the joint to be equal and suggested that the syndesmosis ratio is 1 in normal individuals. The variability in that study may be explained by the fact that the measurements were obtained with a CT scanner using 3-mm axial slices from 9 to 12 mm proximal to the joint, whereas in the current study, the majority of the images were obtained with 1-mm axial slices 10 mm proximal to the joint.

This study has some limitations. Its conclusion is based on the assumption that the femoral transepicondylar axis is the best landmark for neutral rotation of the limb. Other landmarks that may have been used are the tibial condylar axis or the tibial tubercle, but in a pilot study these landmarks were not reliable. Because the current authors’ rotational alignment was determined proximal to the knee, it is possible that rotation may occur through the knee, especially if ligamentous injury or laxity is present, introducing a source of measurement error. Computed tomography scans were evaluated for evidence of acute and prior ligamentous and osseous injury, but the former is more difficult to ascertain.

Conclusion

In accordance with expert opinion, the axis of the distal tibiofibular joint is approximately 30° externally rotated in relation to the transepiondylar plane. Therefore, the reduction tenaculums and transsyndesmotic screws should be placed at this angle to avoid malreduction of the joint. The posterior joint space width is significantly wider than the anterior and central joint spaces. This should be taken into account when using postoperative CT scans to evaluate the accuracy of syndesmotic joint reduction.

References

1. Lindsjo U. Operative treatment of ankle fractures. Acta Orthop Scand Suppl. 1981; 189:1–131.
2. Court-Brown CM, McBirnie J, Wilson G. Adult ankle fractures: an increasing problem?Acta Orthop Scand. 1998; 69(1):43–47. doi:10.3109/17453679809002355 [CrossRef]
3. Pettrone FA, Gail M, Pee D, Fitzpatrick T, Van Herpe LB. Quantitative criteria for prediction of the results after displaced fracture of the ankle. J Bone Joint Surg Am. 1983; 65(5):667–677.
4. Kennedy JG, Johnson SM, Collins AL, et al. An evaluation of the Weber classification of ankle fractures. Injury. 1998; 29(8):577–580. doi:10.1016/S0020-1383(98)00116-8 [CrossRef]
5. Gardner MJ, Demetrakopoulos D, Briggs SM, Helfet DL, Lorich DG. Malreduction of the tibiofibular syndesmosis in ankle fractures. Foot Ankle Int. 2006; 27(10):788–792.
6. Weening B, Bhandari M. Predictors of functional outcome following transsyndesmotic screw fixation of ankle fractures. J Orthop Trauma. 2005; 19(2):102–108. doi:10.1097/00005131-200502000-00006 [CrossRef]
7. Sagi HC, Shah AR, Sanders RW. The functional consequence of syndesmotic joint malreduction at a minimum 2-year follow-up. J Orthop Trauma. 2012; 26(7):439–443. doi:10.1097/BOT.0b013e31822a526a [CrossRef]
8. Hermans JJ, Beumer A, de Jong TA, Kleinrensink GJ. Anatomy of the distal tibiofibular syndesmosis in adults: a pictorial essay with a multimodality approach. J Anat. 2010; 217(6):633–645. doi:10.1111/j.1469-7580.2010.01302.x [CrossRef]
9. Ebraheim NA, Lu J, Yang H, Mekhail AO, Yeasting RA. Radiographic and CT evaluation of tibiofibular syndesmotic diastasis: a cadaver study. Foot Ankle Int. 1997; 18(11):693–698. doi:10.1177/107110079701801103 [CrossRef]
10. Ebraheim NA, Lu J, Yang H, Rollins J. The fibular incisure of the tibia on CT scan: a cadaver study. Foot Ankle Int. 1998; 19(5):318–321. doi:10.1177/107110079801900509 [CrossRef]
11. Elgafy H, Semaan HB, Blessinger B, Wassef A, Ebraheim NA. Computed tomography of normal distal tibiofibular syndesmosis. Skeletal Radiol. 2010; 39(6):559–564. doi:10.1007/s00256-009-0809-4 [CrossRef]
12. Browner BD, Jupiter JB, Levine AM, Trafton PG. Skeletal Trauma. Vol 2. 3rd ed. Philadelphia, PA: WB Saunders; 2003.
13. Phisitkul P, Ebinger T, Goetz J, Vaseenon T, Marsh JL. Forceps reduction of the syndesmosis in rotational ankle fractures: a cadaveric study. J Bone Joint Surg Am. 2012; 94(24):2256–2261. doi:10.2106/JBJS.K.01726 [CrossRef]
14. Pelton K, Thordarson DB, Barnwell J. Open versus closed treatment of the fibula in Maissoneuve injuries. Foot Ankle Int. 2010; 31(7):604–608. doi:10.3113/FAI.2010.0604 [CrossRef]
15. Nielson JH, Gardner MJ, Peterson MG, et al. Radiographic measurements do not predict syndesmotic injury in ankle fractures: an MRI study. Clin Orthop Relat Res. 2005; (436):216–221. doi:10.1097/01.blo.0000161090.86162.19[CrossRef]

Amputación

una publicación de Fisiolab Mex.

Músculos en columna...

una publicación de I.P.C Physical Therapy.

una publicación de Asociación Mexicana De Cirugía de Mano

una publicación de Asociación Mexicana De Cirugía de Mano.

Triple artrodesis / Triple Arthrodesis

http://www.aofas.org/footcaremd/treatments/Pages/Triple-Arthrodesis.aspx

Artrodesis triple
¿Qué es el triple artrodesis ?

Arthodesis Triple se usa para tratar muchos tipos de deformidades en los pies y el dolor. Este procedimiento fusiona tres articulaciones en la parte posterior de

El (flecha verde ) articulaciones talonavicular ( flecha azul) , subastragalina (flecha roja) y calcaneocuboid
el pie . Estas juntas , que se muestra en la imagen a la derecha, son los talonavicular ( flecha azul) , subastragalina (flecha roja ) y el calcáneo (flecha verde).

¿Cuáles son los objetivos de la artrodesis triple ?

Los cirujanos tratan de evitar las fusiones , pero a veces el dolor y la deformidad es tan severa que este procedimiento ofrece la mejor oportunidad de producir un pie menos dolorosa con una mejor alineación. Las fusiones a menudo mejoran la estabilidad y permiten más fácil pararse y caminar . La triple artrodesis es un procedimiento duradero la prueba del tiempo .

¿Qué signos indican la cirugía puede ser necesaria ?

Artrodesis triple está indicado para la artritis severa , inestabilidad o deformidad que no puede ser controlado con los enfoques no quirúrgicos . Otras condiciones, tales como pie plano severo, conexiones anormales entre los huesos , excesivamente altos arcos y la inestabilidad en las articulaciones debido a la enfermedad neuromuscular , también pueden justificar el tratamiento con la fusión .

¿Cuándo debo evitar la cirugía ?

Los pacientes que todavía están creciendo no son candidatos ideales , ya que pueden desarrollar deformidades adicional a medida que crecen . Los pacientes que consumen tabaco , tienen una infección activa o tienen poco potencial de curación están en mayor riesgo de complicaciones. Medidas no quirúrgicas tales como refuerzos y antiinflamatorios se deben intentar primero . Si otro procedimiento quirúrgico que deja intacta la articulación puede lograr el mismo objetivo , esto es preferible a una fusión .

Datos Generales de Procedimientos

Dos incisiones generalmente se requieren para este procedimiento. El método tradicional implica una incisión a cada lado del pie .


Lugares de las incisiones típicas para una triple artrodesis
Dentro de cada uno se quita el cartílago articular, superficies óseas rugosidad y defectos saciados. Una vez que las tres juntas se han preparado , que se ponen en su lugar y el hardware se coloca para estabilizar la reconstrucción y promover la fusión sana.

técnica específica

El cirujano confirma la posición apropiada de los huesos con un tiempo de rayos X en la sala de operaciones. Entonces todas las incisiones son cerradas y cubiertas con apósitos estériles secos voluminosos. Para disminuir el dolor post -operatorio , los nervios alrededor de la rodilla o el tobillo tal vez le adormezcan con medicamentos.

¿Qué sucede después de la cirugía ?

La tasa de curación es variable y depende de muchos factores. En general , el pie se mantiene elevada con ningún peso en él durante las dos primeras semanas para minimizar la inflamación y permitir la cicatrización de la piel. Las puntadas pueden ser quitados dos a tres semanas después de la cirugía .

Diferentes protocolos de soporte de peso pueden ser utilizados . Después de que se observaron signos de cicatrización , se permite que la carga de peso progresiva hasta que se alcance la carga completa . Esto suele tardar tres meses. Una bota removible se puede utilizar en lugar de un yeso.

Posibles complicaciones

El éxito de triple artrodesis es apreciado por los pacientes . La mayoría cree que la pérdida de movimiento es una compensación muy aceptable para la reducción del dolor . En las primeras dos o tres semanas , la complicación más probable es arrollado avería y / o infección. Estos son mejor evitar al no fumar , elevando el pie , evitando cualquier peso en el pie , y mantener el vendaje de la cirugía limpia y seca.

Hay complicaciones que se relacionan con la cirugía en general . Estos incluyen los riesgos asociados a la anestesia , infección, daño a los nervios y los vasos sanguíneos y sangrado o coágulos de sangre .

Los más comunes consecuencia a largo plazo de artrodesis triple es el desarrollo gradual de la artritis en otras articulaciones del pie y el tobillo. Estos cambios pueden tardar años o incluso décadas para desarrollar y muchos nunca llegan a ser perceptible para el paciente.

Preguntas más frecuentes

¿Tendré la rigidez después de la cirugía ?
Sí , usted puede esperar un cierto grado de rigidez en el pie como resultado de la cirugía. Usted mantendrá arriba y hacia abajo un movimiento , pero el movimiento de lado a lado se convertirá limitado. Esto será más apreciable en superficies irregulares , pero suele ser una buena compensación para aliviar el dolor razonable, estabilidad mejorada y / o corrección de la deformidad .

¿Voy a ser capaz de volver a mis actividades habituales?
En general, usted puede esperar para volver a la mayoría de las actividades en la vida , pero la rigidez de movimiento de lado a lado limitará la participación deportiva .

¿Cuándo puedo esperar que se han recuperado de una triple artrodesis ?
Una cantidad significativa de la curación se producirá en los primeros tres meses . Sin embargo , se tarda alrededor de un año para obtener la máxima mejora.

¿Hay efectos secundarios a la artrodesis triple ?
Como una parte del pie se hace más rígido , otras estructuras se ven obligados a aceptar más estrés, lo que aumenta las posibilidades de que puedan llevar a cabo . Esto a menudo lleva muchos años o décadas para convertirse en notable.

¿Cuándo voy a ser capaz de tomar una ducha?
Generalmente, se permite bañarse una vez que todas las heridas han sanado . Esto por lo general se lleva a cabo dentro de los primeros dos a cuatro semanas dependiendo de la hinchazón y la salud de los tejidos blandos .

¿Voy a ser capaz de caber en los zapatos regulares ?
Típicamente los pacientes encajan en un zapato después de la cirugía mejor que antes de la cirugía .

¿Cuándo voy a ser capaz de soportar el peso sobre el pie ?
Soporte de peso parcial se permite normalmente una vez que las incisiones hayan sanado. Rodamiento completo de peso generalmente tarda entre dos y cuatro meses .

El Orthopaedic Foot & Ankle Society americana ( AOFAS ) ofrece información en este sitio como un servicio educativo . El contenido de FootCareMD , incluyendo texto, imágenes y gráficos , es sólo para fines informativos . El contenido no está diseñado para sustituir el asesoramiento médico profesional , diagnóstico o tratamiento . Si usted necesita consejo médico, utilizar "Encontrar un Foot & Ankle Orthopaedic Surgeon " de herramientas en la parte superior de esta página o contacte con su médico de cabecera

Triple Arthrodesis

​What is triple arthrodesis?

Triple arthodesis is used to address many types of foot deformity and pain. This procedure fuses three joints in the back of 

​ The talonavicular (blue arrow), subtalar (red arrow) and calcaneocuboid (green arrow) joints

the foot. These joints, shown in the image to the right, are the talonavicular (blue arrow), subtalar (red arrow) and calcaneocuboid (green arrow).

 

What are the goals of triple arthrodesis?

Surgeons try to avoid fusions, but sometimes pain and deformity are so severe that this procedure offers the best chance of producing a less painful foot with better alignment. Fusions often improve stability and allow for easier standing and walking. The triple arthrodesis is a time-tested, durable procedure.

 

What signs indicate surgery may be needed?

Triple arthrodesis is indicated for severe arthritis, instability or deformity that cannot be controlled with nonsurgical approaches. Other conditions, such as severe flatfoot, abnormal connections between bones, excessively high arches and joint instability due to neuromuscular disease, can also warrant treatment with fusion.

 

When should I avoid surgery?

Patients who are still growing are not ideal candidates as they may develop additional deformity as they grow. Patients who use tobacco, have an active infection or have poor healing potential are at higher risk for complications. Nonsurgical measures such as bracing and anti-inflammatories should be attempted first. If another surgical procedure that leaves the joint intact can achieve the same goal, this is preferred over a fusion.

 

General Details of Procedure

Two incisions are generally required for this procedure. The traditional method involves one incision on each side of the foot.

​ Typical incision sites for a triple arthrodesis

Within each joint cartilage is removed, bony surfaces roughened, and defects filled. Once all three joints have been prepared, they are put into place and hardware is placed to stabilize the reconstruction and promote healthy fusion.

 

Specific Technique

The surgeon confirms proper position of the bones with an X-ray while in the operating room. Then all incisions are closed and covered with bulky dry sterile dressings. To lessen post-operative pain, the nerves around the knee or ankle may be numbed with medication.

 

What happens after surgery?

The rate of healing is variable and is influenced by many factors. In general, the foot is kept elevated with no weight on it for the first two weeks to minimize swelling and allow healing of the skin. Stitches may be removed two to three weeks after surgery.

 

Different weight bearing protocols may be used. After signs of healing are noted, progressive weight bearing is allowed until full weight bearing is reached. This typically takes three months. A removable boot may be used rather than a cast.

 

Potential Complications

Successful triple arthrodesis is appreciated by patients. Most feel that the loss of motion is a very acceptable trade-off for pain reduction. In the first two to three weeks, the most likely complication is wound breakdown and/or infection. These are best avoided by not smoking, elevating the foot, avoiding any weight on the foot, and keeping the surgical dressing clean and dry.

 

There are complications that relate to surgery in general. These include the risks associated with anesthesia, infection, damage to nerves and blood vessels, and bleeding or blood clots.

 

The most common long-term consequence of triple arthrodesis is gradual development of arthritis in other joints of the foot and ankle. These changes can take years or even decades to develop and many never become noticeable to the patient. 

 

Frequently Asked Questions

Will I have stiffness after surgery?

Yes, you can expect some degree of stiffness in your foot as a result of the surgery. You will maintain up-and-down motion, but side-to-side motion will become limited.  This will be most noticeable on uneven surfaces but is usually a good trade-off for reasonable pain relief, improved stability and/or deformity correction.

 

Will I be able to return to my usual activities?
You can generally expect to return to most activities in life, but the stiffness in side-to-side motion will limit sports participation. 

 

When can I expect to have recovered from a triple arthrodesis?
A significant amount of healing will occur in the first three months. However, it takes about one year for maximum improvement.

 

Are there side effects to triple arthrodesis?
As one part of the foot is made stiffer, other structures are forced to accept more stress, which increases the chances that they may wear out. This often takes many years or decades to become noticeable.

When will I be able to take a shower?
Generally, showering is allowed once all wounds have healed. This usually takes place within the first two to four weeks depending on swelling and soft-tissue health.

 

Will I be able to fit into regular shoes?
Typically patients fit into a shoe after surgery better than before surgery.

 

When will I be able to bear weight on my foot?
Partial weight bearing typically is allowed once incisions have healed. Full weight bearing generally takes between two and four months.

The American Orthopaedic Foot & Ankle Society (AOFAS) offers information on this site as an educational service. The content of FootCareMD, including text, images and graphics, is for informational purposes only. The content is not intended to substitute for professional medical advice, diagnoses or treatments. If you need medical advice, use the "Find an Orthopaedic Foot & Ankle Surgeon" tool at the top of this page or contact your primary doctor.

TRACCIÓN

una publicación de Victor Ravens.

http://www.healio.com/orthopedics/spine/news/online/%7Ba3dd1b02-42eb-4f5f-9ac9-d63d830b63dd%7D/carefusion-receives-510k-clearance-for-vertebral-balloon-system

CareFusion receives 510(k) clearance for vertebral balloon system

• February 13, 2014

The FDA has issued 510(k) clearance to CareFusion for its AVAflex Vertebral Balloon System.

According to a company press release, the AVAflex Vertebral Balloon System combines the unique features of the AVAflex Curved Vertebral Augmentation Needle and the AVAmax Vertebral Balloon to enable targeted balloon placement across the midline of the vertebral body, followed by targeted cement placement for optimal fill through a single pedicle. The focus of the AVAmax products is to provide a minimally invasive solution to treat vertebral compression fractures, while also promoting safety for the patient, physician and staff. CareFusion expects a full commercial launch of the AVAflex Vertebral Balloon System in this spring.