A titanium-encased alumina ceramic bearing for total hip arthroplasty: 3- to 5-year results.

UNLABELLED: We examined whether encasing the alumina ceramic total hip arthroplasty insert in a thin titanium sleeve would reduce significantly or eliminate insert chipping on impaction of the insert into the shell. We also compared results, including observations of osteolysis, of the Trident study group with those of the predecessor alumina bearing couple design to determine clinical improvement and radiographic stability. Beginning in October 1996, 328 alumina ceramic bearings were implanted by six surgeons in 316 patients as a part of a prospective, randomized United States Investigational Device Exemption three-arm study comparing an alumina ceramic bearing with a control bearing of cobalt-chromium on polyethylene. In September 1999, a fourth arm of the study (Trident) was added. The Trident insert was recessed within a thin titanium sleeve. At three to five years followup, osteolysis was found in 0% of the patients with the Trident insert and in 0.5% of the patients with an alumina bearing couple. At a mean followup of 4.2 years (range, 3-5 years) no ceramic chips, fractures, or ceramic bearing failures have occurred. Encasing the alumina ceramic insert in a titanium sleeve seems to have resolved the issue of insert chipping on impaction and supports the continued use of Trident bearings in relatively young patients. LEVEL OF EVIDENCE: Therapeutic study, Level II-1 (prospective comparative study-patients treated one way compared with a group of patients treated in another way at the same institution). See the Guidelines for Authors for a complete description of levels of evidence.

RCT Entities:   Population Interventions Outcomes