Abstract
The clinical outcome and radiographic analysis of 82 patients undergoing total hip arthroplasty using a titanium acetabular component coated with a new proprietary Titanium Porous Coating inserted without cement are reported. All total hip replacements were performed by a single surgeon and utilized a porous coated, cementless femoral component. Pre clinical testing was carried out in an animal model to evaluate the new porous coating.
THR was performed using a cementless acetabular component of the same geometrical design inserted without cement. The component is coated with a new proprietary Titanium Porous Coating wherein the non-spherical bead itself is also porous. This creates a “lava rock” type of structure and gives variability in the pore sizes that aids in the in-growth and apposition of bone (fig 5). The inter-bead pore size: the pore size between each non-spherical bead = 200–525 μm while the Intra-bead pore size: the pore size within each non-spherical bead = 25–65 μm. The resulting surface is extremely rough and provides a robust initial “bite” or “stick” to the bone. Clinical results were evaluated using the Harris Hip score and were recorded prospectively preoperatively and at 6 weeks, 6 months, and 1 year postoperatively. Radiographs were evaluated for component migration, subsidence, and cortical and cancellous biologic response as well as zonal analysis of radiolucent lines, using the Muller THR template. Pre-clinical animal testing of the new porous coating was carried out in 50 sheep using a metacarpal intramedulary implant (similar to a hip stem) designed to function as a Percutaneous Osseointegrated Prosthesis (POP) for amputees and evaluated Apposition Bone Index (ABI) (fig 1), Mineral Apposition Rate (MAR) (fig 2),% Bone In-growth (fig 3), and Axial Pull-out Force (fig 4). Sheep were sacrificed at time points of 0, 3, 6, 9, and 12 months to measure and evaluate the above parameters.
Human clinical and radiographic follow up averaged 10.5 months (range 2–18 months). There were 39 females and 43 males. Average age was 59 years. The clinical results were excellent with respect to both pain and function at mid term follow up. Patient satisfaction was high. Radiographic analysis showed no migration or change in the angle of inclination at latest follow up. Femoral component subsidence was detected in 2 cases and averaged 1.8 mm. No polyethylene wear was detected. No hips dislocated. No hips underwent additional surgery. Pre-clinical test data demonstrated excellent mechanical and biological attributes. Average tensile strength of the coating surpassed the FDA minimum requirement by 3X. Animal testing in the sheep showed no evidence of stem loosening or need for revision after 12 months, and corroborated well with clinical results.
Correlation between the pre-clinical testing and the human experience was exceptional. Application of a new titanium porous coating utilizing a proprietary dual pore size structure to the surface of the acetabular component provides an extremely rough surface and robust initial fixation during cementless THR. Excellent early clinical and radiographic results are demonstrated. The addition of this new type of porous coating to other arthroplasty components may confer additional clinical advantages.
