Suffering from Avascular Necrosis of the Ankle?

Reduce Pain and Improve Your
Quality of Life

Reduce Pain and Improve Your Quality of Life

With a Paragon 28 Patient Specific Talus Spacer

Enjoy Recreational
Activities

Continue Your
Career

Better Quality
of Life

Reduce
Pain

Is a Talus Spacer For Me?

If you have been suffering with avascular necrosis of the talus, you may be a candidate for a Patient Specific Talus Spacer. Total talus replacement surgery is expected to provide pain relief and preserve motion in the ankle joint by replacing your damaged talus with a 3D printed replica of your bone.

implant

Anatomy of the Ankle

The ankle is made up of two joints: the ankle joint and the subtalar joint.

The Ankle Joint
• Comprised of three bones: the tibia (shinbone); the fibula; and the talus
• Allows dorsiflexion and plantarflexion of the foot (movement in an up- and-down motion)

The Subtalar Joint
• Consists of the talus on top and calcaneus on the bottom is located beneath the ankle joint
• Allows the foot to move in a side- to-side motion

Along with articular cartilage, ligaments, tendons, and muscles of your lower leg, these components work together to provide stability, strength, and movement to allow you to walk, run, and jump.

lateral foot
anterior foot

Avascular Necrosis

Avascular necrosis (“AVN”) is the death of bone tissue due to a lack of blood supply. Eventually the bone will collapse. If AVN involves the bones of a joint (like the talus) it often leads to destruction of cartilage, resulting in arthritis and pain.

Dhillon MS, Rana B, Panda I, Patel S, Kumar P. Management Options in Avascular Necrosis of Talus.
Indian J Orthop. 2018;52(3):284-296. doi:10.4103/ortho.IJOrtho_608_17

Potential Causes

Avascular necrosis can be caused by:

Traumatic Injury: such as a broken bone or a dislocated joint

Atraumatic Etiology: such as sickle cell anemia, long-term use of high-dose steroid medications, or excessive alcohol intake

Anyone can be affected by AVN, but it is most common in people between the ages of 30 and 50.

Symptoms of AVN of the Talus

Many people have no symptoms in the early stages of avascular necrosis. As the condition worsens, your affected joint might only hurt when you put weight on it. Eventually, you may feel pain when you are lying down. Pain may be dull, mild, or severe and usually develops gradually. Avascular necrosis of the talus can be quite devastating and can lead to total loss of the ankle joint with pain, arthritis, and deformity.

Diagnosis

Your doctor will take X-rays if he or she suspects you may have avascular necrosis. Following X-rays, Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scans will likely be ordered. MRI and CT images are more sensitive than X-rays and are better at helping your doctor identify pathology.

Figure A

This figure shows AVN of the talus as viewed on X-ray

Figure B

This figure shows AVN of the talus as visualized on MRI

Treatment Options

If you have been diagnosed with avascular necrosis (AVN) in the ankle joint, your treatment options will depend on the severity of the avascular necrosis. If AVN is noted in an early stage, non-operative or early stage surgical treatment options may be available. In late stage AVN, if the talus has begun to collapse or has fully collapsed, surgical intervention is required.

Surgical treatment options may include an arthrodesis, or fusion, of one or more joints in the foot and ankle. An arthrodesis eliminates movement at that joint, which assists in relieving pain. Another option is an amputation, where your doctor will surgically remove the lower portion of your limb below the knee. An additional treatment option is available, which is a talus replacement surgery. During this procedure the talus bone is removed and replaced with Paragon 28 Patient Specific Talus Spacer implant. This is considered a joint-sparing procedure, as it allows you to maintain motion of your ankle joint. Your surgeon should discuss appropriate treatment options with you.

Non-Operative Options:

Non-weight bearing or protected weight bearing using splints (patellar braces)

Extracorporeal Shock Wave Therapy (ESWT)

Early Stage Surgical Treatment Options

Core Decompression

Bone Grafting

Late Stage Surgical Treatment Options:

Arthrodesis, or fusion of one or more joints in the foot and ankle. A fusion eliminates movement at that joint to relieve pain.

Amputation, or surgical removal of the lower portion of your limb below the knee

Total Talus Replacement, joint-sparing procedure that allows you to maintain motion in your ankle. The talus bone is removed and replaced with a Paragon 28 Patient Specific Talus Spacer implant.

About Total Talus Replacement

The Paragon 28 Patient Specific Talus Spacer is an alternative treatment option to fusion and amputation, and requires talus replacement surgery. During this procedure the talus bone is removed and replaced with a 3D printed replica of your talus. This is considered a joint-sparing procedure, as it allows you to maintain motion of your ankle joint. In recent years, an increasing number of ankle specialists are beginning to adopt and recommend talus replacement surgery rather than fusions.

implant

Patient Specific Talus Implant

The Paragon 28 Patient Specific Talus Spacer is an additively manufactured, or 3D printed, patient specific implant that is designed and made individually for each patient using CT image data*.

*within 6 months of CT scan date

Download the Patient Brochure

Who should be treated with the Paragon 28 Patient Specific Talus Spacer?

The Paragon 28 Patient Specific Talus Spacer is indicated for avascular necrosis of the ankle joint. Please talk with your doctor to see if you are a candidate for talus replacement surgery. Your doctor will help you to understand the benefits and risks associated with the procedure and determine if you are a candidate for a Paragon 28 Patient Specific Talus Spacer.

Surgeon Testimonial

Foot & Ankle Surgeon

“You are restoring quality of life with this surgery which you cannot do with other available options. We are giving these patients hope for a better quality of life.”

Selene Parekh
MD, MBA, Duke University

How it works

With Total Talus Replacement, the physician replaces the
damaged talus bone with a 3D printed replica of your talus.

The Paragon 28 Patient Specific Talus Spacer is expected to relieve pain and allow you to maintain motion of your ankle joint.

In recent years, an increasing number of ankle specialists are beginning to adopt and recommend talus replacements
rather than fusions.

How it works

With Total Talus Replacement, the physician replaces the damaged talus bone with a 3D printed replica of your talus.

The Patient Specific Talus Spacer is expected to relieve pain and allow you to maintain motion of your ankle joint.

In recent years, an increasing number of ankle specialists are beginning to adopt and recommend talus replacements
rather than fusions.

For more detailed information, please download our patient information guide.

Contact Us

WANT TO LEARN MORE ABOUT TOTAL TALUS REPLACEMENT AND WHAT WE CAN DO FOR YOU?

We Look Forward to Hearing From You

Have a question or comment? We are waiting to hear from you…

Email

PSI@paragon28.com

Mailing Address

44 Riverdale Ave. Monmouth Beach, NJ 07750

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For even more detailed information, please to download our patient information guide.

Humanitarian Device. Authorized by Federal law for use in the treatment of avascular necrosis of the ankle joint. The effectiveness of this device for this use has not been demonstrated.

 https://www.fda.gov/news-events/press-announcements/fda-approves-first-world-first-its-kind-implant-treatment-rare-bone-disease-humanitarian-use-device