Changes in bone mineral density of the proximal tibia after uncemented total knee arthroplasty. A prospective randomized study.

PURPOSE: Regenerex is a novel porous titanium construct with a three-dimensional porous structure and biomechanical characteristics close to that of normal trabecular bone. The aim of this study was to evaluate the adaptive bone remodeling of the proximal tibia after uncemented total knee arthroplasty (TKA) using a tibial tray with this novel coating compared to a well-proven standard porous coated (PPS) tibial tray. MATERIALS: Sixty patients scheduled for TKA were randomized to receive either a Regenerex (n = 31) or a PPS tibial component (n = 29). Changes in bone mineral density (BMD) of the proximal tibia were measured at three, six, 12 and 24 months by dual-energy X-ray absorptiometry (DEXA).
RESULTS: In the lateral region (ROI 3), a significant increase in BMD was seen in both groups at three, six, and 12 months after surgery. The relative increase at 12 months was 8.1 % (P = 0.007) for the PPS group and 6.5 % (P = 0.002) for the Regenerex group. Positive values were retained at 24 months in both groups. At 24 months BMD in the distal region below the central stem (ROI 1) had decreased in the PPS group by 3.4 % (P = 0.005) and in the Regenerex group by 2.4 % (P = 0.17). In the medial region (ROI 2) BMD remained unchanged at all follow-up evaluations in both groups. There were no significant differences between the two groups (P = 0.45) in any ROI at any follow-up evaluation.
CONCLUSION: The significant increase in BMD of the lateral proximal tibia plateau with very limited changes medially and distally seen in both implants suggests that the novel porous titanium construct Regenerex and the PPS implant have a pronounced beneficial effect with regard to maintaining periprosthetic BMD in all regions of interest investigated.

RCT Entities:   Population Interventions Outcomes