THA With Delta Ceramic on Ceramic: Results of a Multicenter Investigational Device Exemption Trial
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Although the published studies on the outcomes of total hip arthroplasty (THA) performed with currently available ceramic components show high survivorship and low bearing wear at midterm followup, concern over ceramic fracture and squeaking persist. For these reasons, the use of ceramic is limited. Recently, a new alumina matrix composite material (Delta ceramic) with improved material properties was developed to address these concerns. We report the early outcomes and complications of a prospective, randomized, multicenter trial of 263 patients (264 hips) at eight centers, comparing a Delta ceramic-on-ceramic (COC) articulation with a Delta ceramic head-crosslinked polyethylene bearing combination (COP). There were 177 COC hips and 87 COP hips. Complications were reported for all patients, whereas clinical and radiographic results were provided for the 233 patients with minimum 2-year followup (average, 31.2 months; range, 21–49 months). The Harris hip scores and clinical, radiographic, and survivorship outcomes were similar in both groups. There were four (2%) revisions in the COC group and two (2%) in the COP group. We encountered three intraoperative ceramic liner-related events. In addition, one patient receiving the COC underwent revision for chipping of the ceramic liner, and a second had ceramic fragmentation on followup radiographs but has not undergone revision. These liner related complications remain a concern. No patient reported squeaking in either group; this leaves us hopeful the new material will lessen the frequency of squeaking. In the short term, the Delta COC articulation provided similar functional scores and survivorship and complication rates with the ceramic head mated with crosslinked polyethylene.
Level of Evidence: Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
KeywordsAlumina Matrix Composite Ceramic Head Femoral Head Fracture Ceramic Liner Ceramic Bearing
We thank additional surgeons and study coordinators (listed respectively by site) who were critical to the study design, enrollment, and followup of this patient cohort: William L. Bargar, MD, and Andrea Hankins (Sacramento, CA); C. Anderson Engh, Jr, MD, Charles A. Engh, Sr, MD, and Supatra Sritulanondha, MPH (Alexandria, VA); Theodore Firestone, MD, and Wayne McBride (Scottsdale, AZ); Robert Molloy, MD, and Lisa Hegemier (Cleveland, OH); Charles Nelson, MD, Craig Isrealite, MD, and Karunya Manikonda (Philadelphia, PA); and David Pollock, MD, and Charlene Cash (Winston-Salem, NC). Study coordinators affiliated with the authors include Donnis Rafferty, CCRC (Denver, CO) and Cheryl Seeley, RN, CCRC (Columbus, OH). Independent radiographic review was performed by Jonathan P. Garino, MD, and Denise Knox (Philadelphia, PA).
- 1.Anwar I, Bhatnagar G, Atrah S. Delayed catastrophic failure of a ceramic head in hybrid total hip arthroplasty. J Arthroplasty. 2009;24:158.e5–8.Google Scholar
- 13.Engh CA Jr, Stepniewski AS, Ginn SD, Beykirch SE, Sychterz-Terefenko CJ, Hopper RH Jr, Engh CA. A randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non-cross-linked Enduron polyethylene liners. J Arthroplasty. 2006;21:17–25.CrossRefPubMedGoogle Scholar
- 17.Hamouche D, Nich C, Bizot P, Meunier A, Nizard R, Sedel L. Fractures of ceramic bearings: history and present status. Clin Orthop Relat Res. 2003;417:19–26.Google Scholar
- 19.Heros RJ, Willman G. Ceramics in total hip arthroplasty: history, mechanical properties, clinical results, and current manufacturing state of the art. Semin Arthroplasty. 1998;9:114–122.Google Scholar
- 34.Rhoads DP, Baker KC, Israel R, Greene PW. Fracture of an alumina femoral head used in ceramic-on-ceramic total hip arthroplasty. J Arthroplasty. 2008;23:1239.e25–30.Google Scholar
- 45.Willmann G. Fiction and facts concerning the reliability of ceramics in THR. In: Zippel H, Dietrich M, eds. Bioceramics in Joint Arthroplasty. Berlin, Germany: Steinkopff Verlag; 2003:193–196.Google Scholar