| CEMENTLESS
TITANIUM-NITRIDE CERAMIC TOTAL HIP REPLACEMENT: |
| 11-Year
Clinical, Radiographic and Survivorship Study |
FREDERICK
F. BUECHEL, SR., M.D.,*, FREDERICK F. BUECHEL, JR., M.D.**,
THOMAS E. HELBIG, M.D.T, JERRY D’ALESSIO, MS†
, MICHAEL J. PAPPAS, Ph.D†
ABSTRACT
A straight-stemmed,
proximally porous coated, femoral component with a modular
32mm diameter head, coated with polished thin film (6 to 10
microns) titanium-nitride-ceramic and utilizing a 30? calcar
loading flange was articulated with an anatomically shaped
porous-coated, hemispherical, acetabular cup, stabilized by
a press-fit technique with or without adjuvant screws for
completely cementless fixation. Titanium-nitride-ceramic coating
was used to provide acceptable wear resistance, minimize torque
at the bearing surface, inhibit abrasion of the stem and prevent
systemic ion leaching from the porous coating. Flexible-lip-locking
acetabular bearings made of GUR 415 polyethylene and sterilized
with ethylene oxide were used to articulate against the femoral
heads.
Clinically
130 total hip replacements in 117 patients were followed over
a 2 to 11.2 year interval mean 6.5 years. Diagnoses were:
103 osteoarthritis, 10 rheumatoid arthritis, 6 posttraumatic
arthritis and 11 avascular necrosis. Ages at the time of surgery
ranged from 30.5 to 90.2 years, mean 66.3 years. Height ranged
from 58 to 76 inches, mean 65.7 inches. Weight ranged from
90 to 300 pounds, mean 179.8 pounds. Harris Hip Scores demonstrated
82.3% excellent, 15.4% good, 2.3% fair and 0% poor results.
Temporary thigh pain limiting activities of daily living was
seen in 0.8% (1/130) hips. Intermittent thigh pain that did
not limit activities of daily living was seen in 4.6% (6/130)
of hips. Kaplan-Meier Survival estimates using an end point
of revision of any component for any reason demonstrated an
overall survival of 95.5% in the 12-year interval. Cementless
fixation survivorship of the acetabular and femoral components
was 98.5% in the 12-year interval. Clinical, radiographic
and survivorship analysis have demonstrated acceptable long
term fixation and function of this cementless hip replacement
device that is cleared for marketing by the Food and Drug
Administration (FDA).
Biomedical
Engineering Technical Report – March 2004
*Department
of Orthopaedic Surgery, UMDNJ-New Jersey Medical School, Newark,
NJ.
**Pennsylvania Hospital, University of Pennsylvania, Adult
Reconstruction Fellow, Philadelphia, PA.
T South Mountain Orthopaedic Associates, South Orange, NJ.
†Department of Mechanical Engineering, New Jersey Institute
of Technology, Newark, NJ
|
