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Integra® Cadence® Total Ankle System


The Integra Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.

The prosthesis is composed of a tibial tray, a talar dome and an insert. Both the tibial tray and talar dome are secured to patient anatomy; the insert is rigidly fixed to the tibial tray intra-operatively. When all three components are implanted, the insert acts as a bearing along the talar dome, enabling flexion and extension movement at the replaced joint.

Each of the three components is available in a variety of sizes and design configurations intended for both primary surgery and revision surgery applications.



Features and Benefits:
  1. Anatomic Implant Designs
    • Side specific (L/R) tibial trays, talar domes, and poly inserts.
    • Anatomic shaped tibial trays for tri- cortical endplate coverage; extended length option and cut out for incisura.
    • Chamfered talar dome.
    • Anatomical articulating surface designed to recreate conical flexion and extension of the ankle
    • Comprehensive selection; 672 possible implant combinations
  2. Designed to preserve patient anatomy
    • Protect and reduce risk of injury to malleoli with customized tibial cut guides and perforating pin technique.
    • Multiple bone prep technique steps performed using same pins.
    • Minimal talar bone resection; total prosthesis height 1-3mm less than competitive ankle systems.1
  3. Designed to reduce dissymmetry and mal-alignment of prosthesis
    • Unique patent pending anterior and posterior biased inserts designed to accommodate patients with subluxed talus in the sagittal plane.
    • Talar tensioning technique step to ensure final implant is placed on horizontal plane, reduce risk of mal-alignment to coronal plane.
  4. Designed for streamlined, repeatable technique
    • Single alignment guide allows for adjustment to patient anatomy.
    • Multiple visualization cues designed into instrumentation for various technique steps.
    • Multiple impaction instruments and anterior chamfer reaming technique enable improved access to surgical site.
    • All instruments contained in two color-coded trays to facilitate procedure flow.





Indications:

The Integra Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. The Integra Cadence Total Ankle System is indicated for use to treat:

  • systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
  • primary arthritis (e.g. degenerative disease)
  • secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved)


Integra Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis, provided sufficient bone stock is present.


NOTE: In the United States, this device is intended for cemented use only.


NOTE: Outside the United States, this device is intended for cemented or cementless use.


Contraindications:

The Integra Cadence Total Ankle System is contra-indicated for:

  • Active infection
  • Skeletally immature
  • Pregnancy
  • Suspected or documented metal allergy or intolerance
  • Severe avascular necrosis of the talus/tibia
  • Severe malalignment or instability that is not surgically correctable
  • Neurological or musculoskeletal disease that may adversely affect gait or weight bearing
  • Participation in activities that may exert excessive loading on joint area and prosthesis
  • Inadequate neuromuscular status (e.g., prior paralysis, neuropathy)
  • Poor bone stock, poor skin coverage, or excessive bone loss around the joint which would make the procedure unjustifiable
  • Obesity
  • Steroid use

The following conditions present an increased risk of failure:

  • Severe osteoporosis; marked bone loss or revision procedures for which an adequate fit of the prosthesis cannot be achieved
  • Osteomalacia
  • Metabolic disorders
  • Demonstrates physiological or anatomical anomalies
  • Undergoing immunosuppressive therapy
  • Malignancy/local bone tumors
  • Compromised wound healing
  • History of mental illness/instability and non-compliance
  • History of drug abuse and/or addiction


WARNING: This device is not intended for subtalar joint fusion or subtalar joint impingement. Please carefully evaluate the anatomy of each patient before implantation.


References
1Comparison of dimensions in printed surgical technical guides, data on file.




For complete product information, please see the Instructions for Use accompanying each product.
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