FDA study finds excellent long-term results in alumina ceramic-ceramic THA
Alumina ceramic-ceramic total hip arthroplasty (THA) is a safe, reliable procedure with excellent long-term survival and a low incidence of component failure and instability, according to Poster Exhibit P074.
The poster exhibit presents the 2-to-8-year results of a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) prospective study of 1, 709 THAs performed by 22 different surgeons from April 1997 to February 2003. A minimum of 2 years of follow-up data was available for 1,074 hips. All patients received alumina ceramic-ceramic bearings. This was one of two studies that led to FDA-clearance of alumina-alumina ceramic bearings in the United States.
Among the 1,709 THAs, there were 18 aseptic revisions for implant-related reasons (1 percent). Two hips were revised for acute instability; one other hip was revised for recurrent instability. Nonimplant-related complications occurred in 21 patients. Researchers found no other cases of wear and no cases with osteolysis. The survivorship rate (based on 8-year Kaplan-Meier Survivorship) is 97 percent (confidence intervals: 93 percent to 100 percent).
Bearing wear and osteolysis are the most common problems affecting the long-term THA results. The introduction of alumina ceramic-ceramic bearings provides orthopaedic surgeons with one method of addressing these problems.
According to the presenters, results from this large FDA/IDE demonstrate that the alumina ceramic-ceramic bearings are reliable and show very few early problems. Ceramic fractures do occur, but rarely. The incidence of component failure and instability is extremely low despite the absence of lipped liners and fewer head-length options. The bearings continue to demonstrate the absence of osteolysis in this series of more than 8 years maximum follow-up.
Investigators include Stephen B. Murphy, MD; Timo M. Ecker, MD; Moritz Tannast, Benjamin E. Bierbaum, MD, all of Boston; Jonathan P. Garino, MD, of Philadelphia; James G. Howe, MD, of Burlington, Vt.; Eric L. Hume, MD of Wynnewood, Penn.; Richard E. Jones, MD, of Dallas; and Kristaps J. Keggi, MD, of Middlebury, Conn. Research support was provided by Wright Medical; Drs. Murphy, Garino and Hume serve as consultants to Wright Medical; in addition, Dr. Garino is a consultant to Depuy and Smith+Nephew.