We report ten-year clinical and radiological
follow-up data for the Sigma Press Fit Condylar total knee replacement system
(Sigma PFC TKR). Between October 1998 and October 1999 a total of
235 consecutive PFC Sigma TKRs were carried out in 203 patients.
Patients were seen at a specialist nurse-led clinic seven to ten
days before admission and at six and 18 months, three, five and
eight to ten years after surgery. Data were recorded prospectively
at each clinic visit. Radiographs were obtained at the five- and
eight- to ten-year follow-up appointments. Of the 203 patients,
147 (171 knees) were alive at ten years and 12 were lost to follow-up.
A total of eight knees (3.4%) were revised, five for infection and
three to change the polyethylene insert. The survival at ten years
with an endpoint of revision for any reason was 95.9%, and with
an endpoint of revision for aseptic failure was 98.7%. The mean
American Knee Society Score (AKSS) was 79 (10 to 99) at eight to
ten years, compared with 31 (2 to 62) pre-operatively. Of 109 knee
with radiographs reviewed, 47 knees had radiolucent lines but none
showed evidence of loosening. Cite this article:
A total of 445 consecutive primary total knee
replacements (TKRs) were followed up prospectively at six and 18 months
and three, six and nine years. Patients were divided into two groups:
non-obese (body mass index (BMI) <
30 kg/m2) and obese
(BMI ≥ 30 kg/m2). The obese group was subdivided into
mildly obese (BMI 30 to 35 kg/m2) and highly obese (BMI ≥ 35
kg/m2) in order to determine the effects of increasing
obesity on outcome. The clinical data analysed included the Knee
Society score, peri-operative complications and implant survival.
There was no difference in the overall complication rates or implant
survival between the two groups. Obesity appears to have a small but significant adverse effect
on clinical outcome, with highly obese patients showing lower function
scores than non-obese patients. However, significant improvements
in outcome are sustained in all groups nine years after TKR. Given
the substantial, sustainable relief of symptoms after TKR and the low
peri-operative complication and revision rates in these two groups,
we have found no reason to limit access to TKR in obese patients.
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The results of 41 consecutive total knee replacements performed on morbidly obese patients with a body mass index >
40 kg/m2, were compared with a matched group of 41 similar procedures carried out in non-obese patients (body mass index <
30 kg/m2). The groups were matched for age, gender, diagnosis, type of prosthesis, laterality and pre-operative Knee Society Score. We prospectively followed up the patients for a mean of 38.5 months (6 to 66). No patients were lost to follow-up. At less than four years after operation, the results were worse in the morbidly obese group compared with the non-obese, as demonstrated by inferior Knee Society Scores (mean knee score 85.7 and 90.5 respectively, p = 0.08; mean function score 75.6 and 83.4, p = 0.01), a higher incidence of radiolucent lines on post-operative radiographs (29% and 7%, respectively, p = 0.02), a higher rate of complications (32% and 0%, respectively, p = 0.001) and inferior survivorship using revision and pain as end-points (72.3% and 97.6%, respectively, p = 0.02). Patients with a body mass index >
40 kg/m2 should be advised to lose weight prior to total knee replacement and to maintain weight reduction. They should also be counselled regarding the inferior results which may occur if they do not lose weight before surgery.