We evaluated a large database with mechanical failure of a single uncemented modular femoral component, used in revision hip arthroplasty, as the end point and compared them to a control group treated with the same implant. Patient- and implant-specific risk factors for implant failure were analyzed. All cases of a fractured uncemented modular revision femoral component from one manufacturer until April 2017 were identified and the total number of implants sold until April 2017 was used to calculate the fracture rate. The manufacturer provided data on patient demographics, time to failure, and implant details for all notified fractured devices. Patient- and implant-specific risk factors were evaluated using a logistic regression model with multiple imputations and compared to data from a previously published reference group, where no fractures had been observed. The results of a retrieval analysis of the fractured implants, performed by the manufacturer, were available for evaluation.Aims
Methods
In 2012 we reviewed a consecutive series of 92
uncemented THRs performed between 1986 and 1991 at our institution
using the CLS Spotorno stem, in order to assess clinical outcome
and radiographic data at a minimum of 21 years. The series comprised
92 patients with a mean age at surgery of 59.6 years (39 to 77)
(M:F 43;49). At the time of this review, seven (7.6%) patients had died and
two (2.2%) were lost to follow-up. The 23-year Kaplan–Meier survival
rates were 91.5% (95% confidence intervals (CI) 85.4% to 97.6%;
55 hips at risk) and 80.3% (95% CI, 71.8% to 88.7%; 48 hips at risk)
respectively, with revision of the femoral stem or of any component
as endpoints. At the time of this review, 76 patients without stem
revision were assessed clinically and radiologically (mean follow-up
24.0 years (21.5 to 26.5)). For the 76 unrevised hips the mean Harris
hip score was 87.1 (65 to 97). Femoral osteolysis was detected in
five hips (6.6%) only in Gruen zone 7. Undersized stems were at
higher risk of revision owing to aseptic loosening (p = 0.0003).
Patients implanted with the stem in a varus position were at higher risk
of femoral cortical hypertrophy and thigh pain (p = 0.0006 and p
= 0.0007, respectively). In our study, survival, clinical outcome and radiographic data
remained excellent in the third decade after implantation. Nonetheless,
undersized stems were at higher risk of revision owing to aseptic
loosening. Cite this article:
The original forged Müller straight stem (CoNiCr) has shown excellent ten- to 15-year results. We undertook a long-term survival analysis with special emphasis on radiological changes within a 20-year period of follow-up. In all, 165 primary total hip replacements, undertaken between July 1984 and June 1987 were followed prospectively. Clinical follow-up included a standardised clinical examination, and radiological assessment was based on a standardised anteroposterior radiograph of the pelvis, which was studied for the presence of osteolysis, debonding and cortical atrophy. Survival of the stem with revision for any reason was 81% (95% confidence interval (CI), 76 to 86) at 20 years and for aseptic loosening 87% (95% CI, 82 to 90). At the 20-year follow-up, 15 of the surviving 36 stems showed no radiological changes. Debonding (p = 0.005), osteolysis (p = 0.003) and linear polyethylene wear (p = 0.016) were associated with aseptic loosening, whereas cortical atrophy was not associated with failure (p = 0.008). The 20-year results of the Müller straight stem are comparable to those of other successful cemented systems with similar follow-up. Radiological changes are frequently observed, but with a low incidence of progression, and rarely result in revision. Cortical atrophy appears to be an effect of ageing and not a sign of loosening of the femoral component.
