Abstract
Purpose
To evaluate the five year Radiostereometric Analysis (RSA) results of the NexGen LPS Trabecular Metal Tibial Monoblock component (TM) and the NexGen Option Stemmed cemented component (Cemented), (Zimmer, Warsaw IN).
Method
70 patients with osteoarthritis were included in a randomized series to receive either the TM implant or the cemented NG component. Surgery was performed by high volume arthoplasty specialists using standardized procedure. RSA exams were obtained postoperatively, at six months, one year, two years and five years. RSA outcomes were translations, rotations and maximum total point motion (MTPM) of the components. MTPM values were used to classify implants as ‘at risk’ or ‘stable’. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores were gathered at all follow-ups.
An analysis of variance was used to test for differences in age, body mass index (BMI), and subjective measures between implant groups. The Kruskal-Wallis test was used to investigate differences in maximum total point motion between implant groups. An analysis of variance was used to test for differences in translations and rotations between groups. Fishers exact test was used to investigate differences in proportions of implants found to be at risk between groups.
Results
At the five year follow-up, 43 patients were able to be reached and were willing to participate in the follow-up exam. There were 25 in the trabecular metal group and 18 in the cemented group. There were no differences in subjective measures (WOMAC) between implant groups at any follow-up.
At the five year follow-up there was no difference in MTPM between the cemented and trabecular metal groups (p=0.94) Compared to the cemented components, the trabecular metal tibial components had significantly higher subsidence than the cemented components (p=0.001). There were no other significant differences.
The proportion of at risk components at five years was 2 of 16 (0.11, 95% CI, 0.03–0.33) in the cemented group and was 0 of 25 (0.0, 95% CI, 0.0–0.13) in the trabecular metal group (p=0.17).
Conclusion
In the two year report on this cohort of patients, we indicated our uncertainty concerning the long term stability of the Trabecular Metal tibial implant due to the high initial migration seen in some cases. In this report we have seen stability of this implant out to five years and migrations in this period below the level of detection of our system in all cases. Given these results it is with increased confidence that we can state that this implant appears to achieve solid fixation despite high initial levels of migration.
