Abstract
BACKGROUND: Ceramic-on-ceramic (COC) bearings in total hip arthroplasty (THA) have long been considered the coupling with the lowest overall wear. However, concerns about complications such as ceramic breakage and noise, combined with the improved performance of polyethylene, have limited its use in the United States. This postapproval follow-up reports long-term (10 years) results of Delta COC in THA patients primarily enrolled in an Investigational Device Exemption study. METHODS: Patients received Delta COC THA in a prospective multicenter study with either 28-mm (N = 105 hips in 104 patients) or 36-mm (N = 81) articulations. Annual clinical and radiographic evaluations were performed for years 5 to 10, and study patients were asked about hip noises and reproducibility. RESULTS: There have been 4 additional reports of noise in 4 patients (COC 28, n = 3; COC 36, n = 1). The cumulative incidence rate for squeaking or noise at 10 years is 5.9% for COC 28 and 13.5% for COC 36. There have been 2 additional reports of dislocation in 2 patients (COC 28, n = 1; COC 36, n = 1). The cumulative incidence rate for dislocation at 10 years is 3.7% for COC 28 and 3.5% for COC 36. At 10 years, there were greater than 40 hips available for follow-up. At mean 10-year follow-up, there were a total of 3 ceramic liner fractures, but none since the previous report. There were no revisions in the 28-mm cohort, and 2 revisions in the 36-mm cohort (1 for recurrent dislocation and 1 for pain and noise). Overall Kaplan-Meier survivorship was 95.96% at 10.5 years (28 mm: 97.68% at 10.2 years; 36 mm: 94.11% at 10.4 years.). CONCLUSIONS: At 10-year follow-up, we report excellent results in regard to survivorship, with one patient revised for pain with associated squeaking.