Saturday, February 26, 2005
Ceramic hip components have low fracture rateBy 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:
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.