Abstract
Introduction
The purpose of this study was to evaluate the long term changes in bone mineral density (BMD) following implantation of a low-modulus composite femoral component designed to closely match the stiffness of the proximal femur and minimize stress shielding. Specifically, we asked: 1) How does BMD in the proximal femur change with time and with Gruen zone location; 2) Does BMD in the proximal femur stabilize after two years of implantation?
Methods
We retrospectively reviewed a subgroup of sixteen patients who had preoperative and postoperative DEXA scans in an FDA multi-center prospective trial of this composite stem. Five of these sixteen patients returned for long-term DEXA scans at a mean 22.0 years post-op (range 21.2–22.6 years). BMD in the 7 Gruen zones at final follow-up was compared to immediate post-operative and 2-year follow-up values. Percentage change was calculated and change in BMD was plotted against time from immediate post-operative measurements to each subsequent follow-up.
Results
At the time of last follow-up, all stems were well fixed with signs of extensive osteointegration. There were no mechanical implant failures.
In Gruen zone 1, patients underwent an overall decrease or little change in BMD, though one patient experienced a notable increase from initial post-op to the latest follow-up. The overall mean (+ SD) annual percent change in BMD in Gruen zone 1 was −0.31% ± 1.09%. When considering the change from the two-year DEXA scan to latest follow-up, two patients demonstrated a decrease in BMD and three patients demonstrated an increase in BMD in Gruen zone 1. All patients demonstrated progressive increase in BMD in Gruen zones 2, 3, 4, 5, and 6 from the initial post-op scan until last follow-up with mean annual percent changes ranging from 0.59% ± 0.50% in Gruen zone 6 to 2.78% ± 2.49% in Gruen zone 3. In our cohort, BMD progressively decreased with time in Gruen zone 7 for all patients with a mean decrease of 1.78% + 0.38% annually from the time of the initial post-op DEXA scan until last follow-up. This was consistent with prior reports with shorter term follow-up.
Conclusions
Despite the extensively porous coated design of this stem and concerns about distal fixation and related stress shielding, we observed consistent DEXA scan evidence of increases in BMD in Gruen zones 2–6 and limitation of decreases in BMD exclusively to zone 7 and to a lesser extent zone 1. This is unlike reported results with several other extensively porous coated and proximally porous coated implants designed to obtain proximal fixation. These increases in BMD occurred despite the potential age-related decreases in BMD in the proximal femur that one would anticipate over the mean 22-year follow-up in this study. Clearly, “normal” physiologic loading of bone after THA is determined by a complex interaction between location of ingrowth, location and extent of endosteal contact of the implant in the proximal femur, stiffness of the stem and other implant design and patient related factors. The long-term observations of this study suggest that effective loading of the proximal femur occurs with this low-modulus stem and that this concept may have a role in the future of THA.
