Similar TKA designs with differences in clinical outcome: a randomized, controlled trial of 77 knees with a mean follow-up of 6 years

Huub J Meijerink, Nico Verdonschot, Corné J M van Loon, Gerjon Hannink, Maarten C de Waalmalefijt, Huub J Meijerink, Nico Verdonschot, Corné J M van Loon, Gerjon Hannink, Maarten C de Waalmalefijt

Abstract

Background and purpose: To try to improve the outcome of our TKAs, we started to use the CKS prosthesis. However, in a retrospective analysis this design tended to give worse results. We therefore conducted a randomized, controlled trial comparing this CKS prosthesis and our standard PFC prosthesis. Because many randomized studies between different TKA concepts generally fail to show superiority of a particular design, we hypothesized that these seemingly similar designs would not lead to any difference in clinical outcome.

Patients and methods: 82 patients (90 knees) were randomly allocated to one or other prosthesis, and 39 CKS prostheses and 38 PFC prostheses could be followed for mean 5.6 years. No patients were lost to follow-up. At each follow-up, patients were evaluated clinically and radiographically, and the KSS, WOMAC, VAS patient satisfaction scores and VAS for pain were recorded.

Results: With total Knee Society score (KSS) as primary endpoint, there was a difference in favor of the PFC group at final follow-up (p = 0.04). Whereas there was one revision in the PFC group, there were 6 revisions in the CKS group (p = 0.1). The survival analysis with any reoperation as endpoint showed better survival in the PFC group (97% (95% CI: 92-100) for the PFC group vs. 79% (95% CI: 66-92) for the CKS group) (p = 0.02).

Interpretation: Our hypothesis that there would be no difference in clinical outcome was rejected in this study. The PFC system showed excellent results that were comparable to those in previous reports. The CKS design had differences that had considerable negative consequences clinically. The relatively poor results have discouraged us from using this design.

Trial registration: ClinicalTrials.gov NCT00228137.

Figures

Figure 1.
Figure 1.
A. Sagittal view of the PFC design (left) and the CKS design (right). B. Anterior view of a computer model of the femoral components. Notice the lateral orientation of the trochlea in PFC (left) and neutral orientation in the CKS component (right). C. Posterior view of the tibial and PE insert components. The central posterior edge of the CKS insert (right) is relatively sharp compared to the PFC insert (left).
Figure 2.
Figure 2.
Flow diagram according to the CONSORT guidelines.
Figure 3.
Figure 3.
Kaplan-Meier survival plots. A. With revision for any reason as endpoint, the PFC group had a survival of 97% (95% CI: 92–100) after 8 years and the CKS group had a survival of 84% (72–96) (p = 0.05). B. With aseptic revision as endpoint, the PFC group had a survival of 97% (92–100) after 8 years and the CKS group had a survival of 89% (78–99) (p = 0.2).
Figure 4.
Figure 4.
Kaplan-Meier survival plots. A. With any reoperation as endpoint, the PFC group had a survival of 97% (95% CI: 92–100) after 8 years and the CKS group had a survival of 79% (66–92) (p = 0.02). B. With aseptic reoperation as endpoint, the PFC group had a survival of 97% (92–100) after 8 years and the CKS group had a survival of 85% (73–97) (p = 0.08).

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