Zimmer Biomet Trabecular Metal™ Total Ankle

Designed to reproduce the ankle’s natural flexibility and motion, the Zimmer Biomet Trabecular Metal Total Ankle is an ankle implant system in harmony with natural anatomy. Created to meet the surgeon's and the patient's needs, this ankle implant features a low profile design, lateral surgical approach and industry-first Prolong® Highly Crosslinked Polyethylene. This innovative ankle replacement and instrument system brings the latest technological advances to total ankle arthroplasty.

The Zimmer Biomet Trabecular Metal Total Ankle is an implant and instrument system engineered to preserve motion in ankle arthroplasty patients. This semiconstrained device is designed to provide joint mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.

The Zimmer Biomet Ankle system consists of three implant components:

  • Talar component
  • Tibial base component
  • Modular tibial articular surface

Six implant sizes are available in anatomic configurations with variable radii of curvature proportional to implant size as in the natural ankle. Three thicknesses of Prolong Highly Crosslinked Polyethylene are also available to facilitate proper ligament balancing.

A lateral transfibular approach is used to potentially reduce the risk of post-operative complications that result from stressing neurovascular structures and disruption angiosomes.1, 2 The anatomic center of rotation is fully visualized and can be more precisely replicated through this approach.

Product Features

Lateral transfibular approach for peace of mind

  • Potential to reduce risk of post-operative complications that result from stressing neurovascular structures and disrupting angiosomes1,2
  • Anatomic center of rotation is fully visualized and can be more precisely replicated
  • Fibular length and implant thickness can be balanced to natural deltoid ligament tension, minimizing stress on deltoid ligament and accompanying talar blood supply

Proprietary alignment and bone preparation system enables simplified precision

  • Alignment frame is intended to make surgery more repeatable and reproducible by providing rigid fixation for bone and instruments
  • Bone resection plane established normal to long axis of tibia to reduce variability in coronal plane alignment
  • Foot remains in plantargrade position during surgery to ensure proper tibio-talar alignment

Advanced implant designed to last

  • Prolong Highly Crosslinked Polyethylene bearing surface engineered to reduce volumetric wear3,4
  • Curved bone-implant interface designed to minimize subsidence
  • Rails oriented in coronal plane to stabilize implant against normal joint motion
  • Semi-conforming articulation designed to limit point loading when varus/valgus stresses are present

Anatomic articulation restores natural motion

  • Bicondylar, conical articulation designed to allow for more normal integration with tendon and muscular function and reproduce natural motion path of ankle
  • Accommodates axial rotation and A/P translation motions found in normal walking gait
  • Six implant sizes available in anatomic configurations, with variable radii of curvature proportional to implant size, as in the natural ankle

1. Gill LH. Challenges in Total Ankle Arthroplasty. Foot and Ankle International, 2004;Vol. 25, No. 4: 195-207.

2. Saltzman CL, et al. Prospective Controlled Trial of STAR Total Ankle Replacement Versus Ankle Fusion: Initial Results. Foot and Ankle International, 2004;Vol. 30, No. 7: 579-596.

3. Data on file at Zimmer.

4. Gsell R, Yao JQ, Laurent MP, Crowninshield RD: Improved oxidation resistance of highly crosslinked UHMWPE for total knee arthroplasty. Society for Biomaterials 27th Annual Meeting Transactions, 84, 2001.

5. Bell, C.J., Fisher J, “Simulation of Polyethylene Wear in Ankle Joint Prostheses”, J Biomed. Mater Res. Part B: Appl. Biomater., 81B: 162-167, 2007. 6. Inman V The Joints of the Ankle. Williams and Wilkins 1976.

Product Technology

Prolong® Highly Crosslinked Polyethylene

Prolong Highly Crosslinked Polyethylene has a heritage of more than 10 years of clinical use as a bearing material in total knee arthroplasty. In total knee arthroplasty, wear, delamination, pitting and cracking in conventional polyethylene occur from the combined effects of surface stress, subsurface fatigue and oxidation1. Due to the virtual elimination of free radicals, Prolong Polyethylene is designed to resist oxidation, reduce surface wear and reduce subsurface fatigue1. Prolong Polyethylene has been shown to reduce oxidation through the virtual elimination of free radicals.1

1. Gsell R, Yao JQ, Laurent MP, Crowninshield RD: Improved oxidation resistance of highly crosslinked UHMWPE for total knee arthroplasty.

Society for Biomaterials 27th Annual Meeting Transactions, 84, 2001.

Intended Use

Indications

Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint. The Zimmer Biomet Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with:

  • Rheumatoid arthritis
  • Post-traumatic arthritis
  • Degenerative arthritis

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

Contraindications

  • Local/systemic infection that may affect the prosthetic joint
  • Previous history of infection in the affected joint is a relative contraindication
  • Insufficient bone stock or bone quality
  • Skeletal immaturity
  • Severe instability, maltracking or misalignment of the tibia and talus (unless correctable by surgery)
  • Charcot’s disease
  • Loss of musculature or neuromuscular compromise in the affected limb
  • Severe osteoporosis
  • Severe neurological or vascular disease affecting the extremity
  • Ankle arthrodesis with malleolar exeresis
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References

1. Gill LH. Challenges in Total Ankle Arthroplasty. Foot and Ankle International, 2004; Vol. 25, No. 4: 195-207.

2. Saltzman CL, et al. Prospective Controlled Trial of STAR Total Ankle Replacement Versus Ankle Fusion: Initial Results. Foot and Ankle International, 2004;Vol. 30, No. 7: 579-596.

 

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Zimmer, Inc.
1800 West Center Street
Warsaw, Indiana 46580 USA

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