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Zimmer, Inc.

Trabecular Metal™ Modular Acetabular System

Product Description

The integration of Trabecular Metal Material and modularity into a proven implant design provides a wide variety of shell and liner options to address specific patient needs.

The elliptical shape of the cup creates an interference fit with the spherically reamed acetabulum. From the pole of the dome, the interference fit increases until a 2-mm differential is achieved at the face of the cup. This maximizes bone contact and enhances initial stability.

A proprietary locking mechanism helps prevent dislocation of the liner from the shell, yet allows easy disassembly without damaging the liner. Liner security is complemented by antirotational tabs, and micromotion is minimized by full congruency between the liner and shell.1

Combining the Trilogy® Acetabular System design with the proven benefits and biologic in-growth potential of Trabecular Metal Material presents a unique option for total hip arthroplasty.

Trabecular Metal shell configurations include Non-holed, Cluster-holed, and Multi-holed. These shells can be used with any of the Trilogy Acetabular Liners.

Acetabular liners are available in Longevity® Cross-linked Polyethylene.

References

  1. Doehring T.C.,Saigal S., Shanbag A.S., Rubash H.E. Micromotion of acetabluar liners: Measurements comparing the effectiveness of locking mechanisms. Orthopaedic Research Society, 42nd Annual Meeting, 1996.

Cleaning Instructions

This device is provided sterile by gamma irradiation as indicated by the <Sterile | R> symbol on the labeling. It remains sterile as long as the package integrity has not been violated. Inspect each package prior to use and do not use the component if any seal or cavity is damaged or breached or if the expiration date has been exceeded. Once opened, the component must be used or discarded.

Surgical Techniques and Related Guides

Trabecular Metal Material

Trabecular Metal Material possesses a substantially higher coefficient of friction on cancellous bone than other implant materials.1 This property facilitates direct bone apposition2,3 to increase initial stability at implantation.

Bone interface shear strength (MPa) of Trabecular Metal Material is higher compared to other fixation surfaces.4,5 Trabecular Metal Material is made from Tantalum, one of the most inert elemental metal biomaterials available, Trabecular Metal Material has a cellular structure and material properties that are remarkably similar to those of cancellous bone. Its three-dimensional architecture provides for a high-friction bone interface for a scratch fit and excellent initial implant stability. In addition, interconnecting pores enable rapid and extensive bone formation and ingrowth to achieve long-term fixation.

Longevity Crosslinked Polyethylene

Crosslinking has been shown to reduce the wear rate of polyethylene by up to 89% in laboratory studies.6 Clinical experience with highly crosslinked polyethylenes has also demonstrated a substantial reduction in the rate of wear.7,8 This remarkable process creates a three-dimensional structure that is more resistant to abrasion.9,10
Longevity Highly Crosslinked Polyethylene was developed to address the issue of wear in total hip arthroplasty. To help ensure optimal wear resistance, Zimmer employs a proprietary process based in part on patents licensed from Massachusetts General Hospital and the Massachusetts Institute of Technology. Using high-dose electron-beam radiation, this process fully crosslinks broken molecular polyethylene chains, leaving virtually no free radicals to promote oxidation.

The process produces a 10-fold wear rate reduction—an average 89% reduction of debris generated—compared to standard polyethylene control samples.6 The material also meets all of the mechanical property requirements of the ASTM and ISO standards. Longevity Crosslinked Polyethylene is available with the Continuum ® Acetabular System, Trabecular Metal™ Modular Acetabular System, and Trilogy ® Acetabular System, which is based on the long Zimmer tradition of clinical success with the Harris-Galante™ and HGP II porous cups.

Technology References

  1. Bobyn JD, Hacking SA, Chan SP, et al. Characterization of a new porous tantalum biomaterial for reconstructive orthopaedics. Scientific Exhibit, Proc of AAOS, Anaheim, CA. 1999.
  2. Goldberg VM, Stevenson S, Feighan J, et al. Biology of grit blasted titanium alloy implants. Clin Orthop. 1995;319:122-129.
  3. Hacking SA, Bobyn JD, Toh K-K, et al. The osseous response to corundum blasted implant surfaces in a canine total hip arthroplasty model. Clin Orthop. 1999;364:240-253.
  4. Bobyn JD, Hacking SA, Chan SP, et al. Characterization of new porous tantalum biomaterial for reconstructive orthopaedics. Scientific Exhibition: 66th Annual Meeting of the American Academy of Orthopaedic Surgeons; 1999; Anaheim, CA.
  5. Bobyn JD, Stackpool G, Toh K-K, et al. Characteristics of bone ingrowth and interface mechanics of a new porous tantalum biomaterial. J Bone Joint Surg.1999;81-B:907-914.
  6. Data on file at Zimmer, Inc.
  7. Oonishi H, Saito M, Kadoya Y. Wear of high-dose gamma irradiated polyethylene in total joint replacement – longterm radiological evaluation. 44th Annual Meeting, Orthopaedic Research Society, March 16-19, 1998.
  8. Wroblewski BM, Siney PD, Fleming PA. Low-friction arthroplasty of the hip using alumina ceramic and crosslinked polyethylene. J Bone Joint Surg (Br). 1999; 81-B: 54-5.
  9. Grobbelaar CJ, DuPlessis TA, Marais F. The radiation improvement of polyethylene prosthesis. J Bone Joint Surg. 1978;60-B(3):370-374.
  10. Oonishi H, Kuno M, Ikada Y, et al. Super low wear crosslinked UHMWPE by heavy high-dose gammaradiation. Proceedings from the 2nd Congress of Hip Section of Western Pacific Orthopaedic Assn. 1996;4.
  11. Bragdon, CR, et al., Seven to Ten Year Follow-Up of Highly Crosslinked Polyethylene Liners in Total Hip Arthroplasty, Poster No. 2444, 55th Annual Meeting of the Orthopaedic Research Society, Las Vegas, 2009.
  12. Data on File at Zimmer.
  13. Muratoglu OK, et al., The comparison of the wear behavior of four different types of crosslinked acetabular components. 46th Annual Meeting of the Orthopaedic Research Society. Paper 0566. 2000.

Indications

This device is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

This device is intended for either cemented or noncemented use.

Contraindications

Contraindications include osteoradionecrosis, skeletal immaturity, any neuromuscular disease in the affected limb, and systemic or local infection.

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