Unacceptable failure rate of a ceramic-coated posterior cruciate-substituting total knee arthroplasty

Abstract

Background Aseptic loosening is one of the most elusive problems in total knee arthroplasty. We compared the failure rates of posterior cruciate-substituting total knee arthroplasty utilizing implants with hardened surface coating to a previous cohort of patients who underwent the procedure with traditional cruciate-retaining noncoated cobalt-chrome implants. Methods A retrospective study was conducted of 1099 total knee arthroplasties performed from 2009 to 2017. Two hundred forty-nine total knee arthroplasties performed from January 2015 to March 2017 under a single design were reviewed retrospectively and compared to the author’s previous 850 total knee arthroplasties performed from January 2009 to December 2014 under a different design. Results This series demonstrated an alarming debonding of cement in the tibial implant. The resultant failure rate of 6% ( P < .001) is higher than observed in 850 total knee arthroplasties in the previous 5 years and higher than those reported in the literature giving cause for concern regarding this implant. Conclusions Due to the observed excessive failure rate, the authors recommend exercising high levels of caution using this implant with hardened surface treatment until further testing can be ascertained as to the root cause of failure.

Tibial Implant Fixation Behavior in Total Knee Arthroplasty: A Study With Five Different Bone Cements

“…series an unacceptable failure rate of 6% prior to 1-year follow-up (15 aseptic loosenings out of a cohort of 249 TKAs implanted from 2015 to 2017) in comparison to a previously implanted cohort of 850 Columbus cruciate-retaining knees (2009-2014) with only 2 known revisions due to aseptic loosening (0.24%). They hypothesized that the new design of the Vega PS tibial tray may be a factor to be considered for their unfavorable clinical outcomes [48]. These findings are in contrast to the promising short-term clinical behavior of the Vega PS knee system reported by Jain et al [44].…”

“…For the ZrN multilayer-coated Vega PS knee system, Lionberger et al [48] reported in a retrospective study on a single surgeon case Fig. 10.…”

“…In 3 cohorts they compared the clinical outcomes of 206 consecutive TKAs using Vega PS with those of 2 clinically long-term established posterior-stabilized designs (e.motion PS n ¼ 205; Genesis II n ¼ 216) in a 2-year follow-up study and found comparable or superior functional clinical performance of Vega PS without incidence of implant-related adverse events [44]. Lionberger et al [48] further hypothesized that the ceramic hardened implant surface may be a potential factor for limited cement adhesion and early debonding in the later loosenings and proposed further testing to ascertain the root cause for these failures, but his cementation technique lists that he was using Palacos R and cementing in the late window we investigated in this study and he also lists 2 other cementation techniques that are specifically contrary to manufacturer recommendations. The current study, including the results of this detailed evaluation and testing, showed a high interface fixation strength of the cemented Vega PS tibial plateau without significant differences between the CoCrMo and the ZrN multilayer surface version.…”

Implant Interface Debonding After Total Knee Arthroplasty: A New Cause for Concern?

“…Similar to this case series, previous studies have not been able to determine an exact etiology for the debonding. A range of possible hypotheses has been postulated including using HVC during the TKA, the specific cement application technique, and even the implant design [ [3] , [4] , [5] , [6] , [8] , [9] , [10] ]. The majority of these studies were published in the last 5 years and are not necessarily related to polyethylene wear (which may be a late factor in debonding cases).…”

“…Past studies have linked certain implants as potential risk factors for implant-cement interface debonding in TKA [ 3 , 4 , 8 ]. For example, one retrieval analysis study of low-contact-stress mobile-bearing TKA found a negative correlation between the cement mantle thickness rates of debonding.…”