We report the five-year outcome of a randomised
controlled trial which used radiostereometric analysis (RSA) to assess
the influence of surface oxidised zirconium (OxZr, Oxinium) on polyethylene
wear A total of 120 patients, 85 women and 35 men with a mean age
of 70 years (59 to 80) who were scheduled for primary cemented total
hip arthroplasty were randomly allocated to four study groups. Patients
were blinded to their group assignment and received either a conventional
polyethylene (CPE) or a highly cross-linked (HXL) acetabular component
of identical design. On the femoral side patients received a 28
mm head made of either cobalt-chromium (CoCr) or OxZr. The proximal head penetration (wear) was measured with repeated
RSA examinations over five years. Clinical outcome was measured
using the Harris hip score. There was no difference in polyethylene wear between the two
head materials when used with either of the two types of acetabular
component (p = 0.3 to 0.6). When comparing the two types of polyethylene
there was a significant difference in favour of HXLPE, regardless
of the head material used (p <
0.001). In conclusion, we found no advantage of OxZr over CoCr in terms
of polyethylene wear after five years of follow-up. Our findings
do not support laboratory results which have shown a reduced rate
of wear with OxZr. They do however add to the evidence on the better
resistance to wear of HXLPE over CPE. Cite this article:
We performed a randomised controlled trial comparing
computer-assisted surgery (CAS) with conventional surgery (CONV)
in total knee replacement (TKR). Between 2009 and 2011 a total of
192 patients with a mean age of 68 years (55 to 85) with osteoarthritis
or arthritic disease of the knee were recruited from four Norwegian
hospitals. At three months follow-up, functional results were marginally
better for the CAS group. Mean differences (MD) in favour of CAS
were found for the Knee Society function score (MD: 5.9, 95% confidence
interval (CI) 0.3 to 11.4, p = 0.039), the Knee Injury and Osteoarthritis
Outcome Score (KOOS) subscales for ‘pain’ (MD: 7.7, 95% CI 1.7 to
13.6, p = 0.012), ‘sports’ (MD: 13.5, 95% CI 5.6 to 21.4, p = 0.001)
and ‘quality of life’ (MD: 7.2, 95% CI 0.1 to 14.3, p = 0.046).
At one-year follow-up, differences favouring CAS were found for
KOOS ‘sports’ (MD: 11.0, 95% CI 3.0 to 19.0, p = 0.007) and KOOS
‘symptoms’ (MD: 6.7, 95% CI 0.5 to 13.0, p = 0.035). The use of
CAS resulted in fewer outliers in frontal alignment (>
3° malalignment),
both for the entire TKR (37.9% Cite this article:
We evaluated the rates of survival and cause
of revision of seven different brands of cemented primary total
knee replacement (TKR) in the Norwegian Arthroplasty Register during
the years 1994 to 2009. Revision for any cause, including resurfacing
of the patella, was the primary endpoint. Specific causes of revision
were secondary outcomes. Three posterior cruciate-retaining (PCR) fixed modular-bearing
TKRs, two fixed non-modular bearing PCR TKRs and two mobile-bearing
posterior cruciate-sacrificing TKRs were investigated in a total
of 17 782 primary TKRs. The median follow-up for the implants ranged
from 1.8 to 6.9 years. Kaplan-Meier 10-year survival ranged from
89.5% to 95.3%. Cox’s relative risk (RR) was calculated relative
to the fixed modular-bearing Profix knee (the most frequently used
TKR in Norway), and ranged from 1.1 to 2.6. The risk of revision
for aseptic tibial loosening was higher in the mobile-bearing LCS
Classic (RR 6.8 (95% confidence interval (CI) 3.8 to 12.1)), the
LCS Complete (RR 7.7 (95% CI 4.1 to 14.4)), the fixed modular-bearing
Duracon (RR 4.5 (95% CI 1.8 to 11.1)) and the fixed non-modular
bearing AGC Universal TKR (RR 2.5 (95% CI 1.3 to 5.1)), compared
with the Profix. These implants (except AGC Universal) also had
an increased risk of revision for femoral loosening (RR 2.3
(95% CI 1.1 to 4.8), RR 3.7 (95% CI 1.6 to 8.9), and RR 3.4 (95%
CI 1.1 to 11.0), respectively). These results suggest that aseptic
loosening is related to design in TKR. Cite this article:
In this prospective study we studied the effect
of the inclination angle of the acetabular component on polyethylene wear
and component migration in cemented acetabular sockets using radiostereometric
analysis. A total of 120 patients received either a cemented Reflection
All-Poly ultra-high-molecular-weight polyethylene or a cemented
Reflection All-Poly highly cross-linked polyethylene acetabular
component, combined with either cobalt–chrome or Oxinium femoral
heads. Femoral head penetration and migration of the acetabular
component were assessed with repeated radiostereometric analysis
for two years. The inclination angle was measured on a standard
post-operative anteroposterior pelvic radiograph. Linear regression
analysis was used to determine the relationship between the inclination
angle and femoral head penetration and migration of the acetabular component. We found no relationship between the inclination angle and penetration
of the femoral head at two years’ follow-up (p = 0.9). Similarly,
our data failed to reveal any statistically significant correlation
between inclination angle and migration of these cemented acetabular
components (p = 0.07 to p = 0.9).
We have compared the survival of two hydroxyapatite (HA)-coated cups, 1208 Atoll hemispheric and 2641 Tropic threaded, with cemented Charnley all-polyethylene cups (16 021) using the Cox regression model. The Tropic cup used in combination with an alumina ceramic femoral head, had good results, similar to those of the Charnley cup. When used in combination with a stainless-steel head, however, the risk of revision beyond four years was increased 3.4 times for the Tropic cup compared with the Charnley cup (p <
0.001). Over the same period, the Atoll cup had an increased risk of revision of 3.8 times when used with the alumina heads (p <
0.001) and an increased risk of 6.1 times when used with stainless-steel heads (p <
0.001). Revision because of wear and osteolysis was more common with both types of HA-coated cup than with the Charnley cup. The rate of revision of the Atoll cup because of aseptic loosening was also increased. We found that HA-coated cups did not perform better than the Charnley cup.
Using data from the Norwegian Arthroplasty Register, we have the assessed survival of 17 323 primary Charnley hip prostheses in patients with osteoarthritis based upon the type of cement used for the fixation of the implant. Overall, 9.2% had been revised after follow-up for ten years; 71% of the failures involved aseptic loosening of the femoral component. We observed significantly increased rates of failure for prostheses inserted with CMW1 and CMW3 cements. Using implants fixed with gentamicin-containing Palacos cement as the reference, the adjusted Cox regression failure rate ratios were 1.1 (95% CI 0.9 to 1.4) for implants cemented with plain Palacos, 1.1 (95% CI 0.7 to 1.6) for Simplex, 2.1 (95% 1.5 to 2.9) for gentamicin-containing CMW1, 2.0 (95% CI 1.6 to 2.4) for plain CMW1 and 3.0 (95% CI 2.3 to 3.9) for implants fixed with CMW3 cement. The adjusted failure rate at ten years varied from 5.9% for implants fixed with gentamicin-containing Palacos to 17% for those fixed with CMW3.
We studied the rates of revision for 53 698 primary total hip replacements (THRs) in nine different groups of disease. Factors which have previously been shown to be associated with increased risk of revision, such as male gender, young age, or certain types of uncemented prosthesis, showed important differences between the diagnostic groups. Without adjustment for these factors we observed an increased risk of revision in patients with paediatric hip diseases and in a small heterogeneous ‘other’ group, compared with patients with primary osteoarthritis. Most differences were reduced or disappeared when an adjustment for the prognostic factors was made. After adjustment, an increased relative risk (RR) of revision compared with primary osteoarthritis was seen in hips with complications after fracture of the femoral neck (RR = 1.3, p = 0.0005), in hips with congenital dislocation (RR = 1.3, p = 0.03), and in the heterogenous ‘other’ group. The analyses were also undertaken in a more homogenous subgroup of 16 217 patients which had a Charnley prosthesis implanted with high-viscosity cement. The only difference in this group was an increased risk for revision in patients who had undergone THR for complications after fracture of the femoral neck (RR = 1.5, p = 0.0005). THR for diagnoses seen mainly among young patients had a good prognosis, but they had more often received inferior uncemented implants. If a cemented Charnley prosthesis is used, the type of disease leading to THR seems in most cases to have only a minor influence on the survival of the prosthesis.
We have assessed the effect of different regimes of antibiotic prophylaxis on the survival of total hip implants, comparing antibiotics administered both systemically and in the bone cement, systemically only, in the bone cement only and with no antibiotics given. We studied 10 905 primary cemented total hip replacements, performed for osteoarthritis of the hip and reported to the Norwegian arthroplasty register between 1987 and 1995. Cox-estimated failure-rate ratios (FRR) are presented with adjustment for gender, age, the brand of cement, the prosthesis, the type of operating theatre and the operating time. For revisions performed for infection (39 operations), the lowest rate of revision was found among patients receiving antibiotic-containing cement plus systemic antibiotics (n = 5804). The revision rate for the 4586 patients receiving systemic antibiotics only was 4.3 times greater (95% CI 1.7 to 11.0, p = 0.001); in 239 with antibiotics in the bone cement only it was 6.3 times greater (CI 1.6 to 25.0, p = 0.003); and in the 276 who did not receive antibiotics it was by 11.5 times greater (CI 2.1 to 63.0, p = 0.002). Adjustment for the total amount of systemic antibiotic administered did not change the results. We also observed an increased revision rate for aseptic loosening (109 operations) comparing the systemic-only (FRR = 1.8, CI 1.1 to 2.9, p = 0.01) and the cement-only regimes (FRR = 2.6, CI 1.2 to 5.9, p = 0.02) with the combined dosage. Our findings show that systemic antibiotics combined with antibiotic-containing bone cement led to fewer revisions than the other methods.
The Norwegian Arthroplasty Register recorded 24,408 primary total hip replacements from 1987 to 1993; 2907 of them (13%) were performed with uncemented femoral components. We have compared the results of eight different designs, each used in more than 100 patients. Survivorship of the components was estimated by the Kaplan-Meier method using revision for aseptic loosening of the femoral component as the end-point. At 4.5 years, the estimated probability of revision for aseptic loosening for all implants was 4.5%, for the Bio-Fit stem 18.6% (n = 210) and for the Femora stem 13.6% (n = 173). The PM-Prosthesis and the Harris/Galante stem prostheses needed revision in 5.6% and 3.6%, respectively. The clockwise threaded stem of the Femora implant needed revision in 20% of right hips, but in only 4% of left hips. The short-term results of the four best uncemented femoral components (Corail, LMT, Profile and Zweimuller) were similar to those for cemented stems, with revision for loosening in less than 1% at 4.5 years. The importance of the control of innovative designs and the registration of early results is discussed.