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Today's News

Saturday, February 26, 2005

Ceramic hip components have low fracture rate

By Kathleen Misovic

Fracture rates for ceramic hip replacement components are very low and continue to improve, according to researchers for Scientific Exhibit SE008.

Although variable fracture rates for ceramic hip replacement components have been reported in the literature, many of these studies include obsolete designs and previous generations of ceramic grades. Additionally, the compilation of data on fractures has improved significantly due to the imposition of critical event reporting requirements. Researchers analyzed the database of the largest supplier of medical-grade ceramic components to determine the demographics of modern ceramic component fractures from 2000 to 2003.

Based on more than one million components produced during the three years, they found a current fracture rate of just 0.015 percent. Additional important findings include:

  1. Ceramic 28 mm balls fractured at three times the rate of ceramic 32mm balls.
  2. Medium-length 28mm balls fractured at one-third the rate of the short or long 28mm balls
  3. Approximately 90 percent of fractures occur within 36 months of implantation.
  4. The expected fracture rate of balls and liners dropped from 0.024 percent in 2001 to 0.015 percent in 2003.
  5. Fracture rates of the identical ceramic component among different manufacturers vary between 0.042 percent and to 0.000 percent, indicating influence by prosthetic manufacturers.
  6. The reported fracture rate is lower than the expected rate for components produced in 2000 and 2001 (components in service for a sufficient time).

Reseachers found that current ceramic component fracture rates are very low and continue to improve with education and quality improvement efforts. Stricter reporting requirements by the Food and Drug Administration and critical event reporting requirements have alleviated concerns of under-reporting fractures due to ceramic components.

Whenever possible, researchers recommend using larger (32mm) ball heads The overall fracture rate of 0.015 percent compares successfully with other complications requiring revision such as infection, stem breakage, metal allergy and dislocation.

Investigators include Jonathan P. Garino, MD; Reema Marks, BA; and Dinh Vu, BSE, all of Philadelphia, and Stefen Leyen, PhD, of Polchingen, Germany. Drs Garino and Leyen are consultants with Ceramtec; Dr. Garino also serves as a consultant to Depuy and Smith & Nephew.

 
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