Seventy-four primary total hip arthroplasties were performed in
sixty-eight patients between August 1990 and September 1991. Clinical
assessments were made with use of the Harris hip score and, specifically,
the pain component of that score. The preoperative radiographs were
digitally quantified for calculation of the so-called canal-to-calcar ratio
and the so-called cortical index. The postoperative radiographs were
evaluated for the percentage of the cross-sectional area of the femoral
canal that was occupied by the prosthesis; subsidence of the prosthesis;
and adaptive osseous changes, including hypertrophic cortical remodeling,
osteolysis, formation of sclerotic radiolucent lines around the prosthesis,
and formation of a pedestal at the tip of the prosthesis. The indication
for the arthroplasty was osteoarthrosis in fifty hips (68 per cent),
avascular necrosis in fourteen (19 per cent), congenital dysplasia in six
(8 per cent), and another diagnosis in four (5 per cent). The average
duration of follow-up was thirty-one months (range, eleven to forty-six
months). The average Harris hip score (and standard deviation) was 75 +/-
16.8 points (range, 29 to 100 points), and the average score for the pain
component was 37 +/- 7.5 points (range, 0 to 44 points). The average
canal-to-calcar ratio of the hips was 0.44 (range, 0.32 to 0.74), and the
average cortical index was 0.54 (range, 0.33 to 0.66). The average
subsidence of the component was 0.6 centimeter (range, 0.0 to 2.3
centimeters). The average fill of the canal was 100 per cent proximally, 97
per cent at the middle of the stem, and 92 per cent distally as measured on
the anteroposterior radiographs made immediately postoperatively and 100,
95, and 90 per cent, respectively, as measured on the lateral radiographs.
A failure occurred in twenty-one hips (28 per cent) in twenty-one patients,
with an average time to failure of 21 +/- 13 months (range, one to
forty-four months). The Kaplan-Meier survival estimate (and standard error)
for this population was 0.45 +/- 0.11 (confidence interval, 0.67 to 0.23)
at forty-four months. The average subsidence of the components that failed
was 0.7 centimeter (range, 0.1 to 2.3 centimeters). There was no
significant relationship between failure of the component and the age or
sex of the patient, the diagnosis, or the side of the operation.
Postoperative severity of pain (p = 0.09) or subsidence (p = 0.08) alone
did not reach significance for predicting outcome. The Harris hip score
alone (p = 0.05), the Harris hip score in combination with subsidence of
the femoral component (p = 0.01), and the pain component of the Harris hip
score in combination with subsidence of the femoral component (p = 0.01)
were all significant for predicting outcome. No other measured radiographic
variable was predictive of failure. Despite optimization of the fit of the
component within the femoral canal and the percentage of the
cross-sectional area of the femoral canal occupied by the component, the
clinical results indicated a high rate of failure. Thus, these criteria are
not the only requisites for stabilization of these femoral components
without cement. On the basis of these data, we have discontinued the use of
these intraoperatively customized, non-porous, smooth femoral
prosthesis.