The properties and performance of a new low-monomer cement were examined in this prospective randomized, controlled RSA study. 5-year data have already been published, showing no statistically significant differences compared to controls. In the present paper we present the 10-year results.
44 patients were originally randomized to receive total hip replacement with a Lubinus SPII titanium-aluminum-vanadium stem cemented either with the new Cemex Rx bone cement or with control bone cement, Palacos R. Patients were examined using RSA, Harris hip score, and conventional radiographs.
At 10 years, 33 hips could be evaluated clinically and 30 hips could be evaluated with RSA (16 Cemex and 14 Palacos). 9 patients had died and 4 patients were too old or infirm to be investigated. Except for 1 hip that was revised for infection after less than 5 years, no further hips were revised before the 10-year follow-up. There were no statistically significant clinical differences between the groups. The Cemex cement had magnitudes of migration similar to or sometimes lower than those of Palacos cement. In both groups, most hips showed extensive radiolucent lines, probably due to the use of titanium alloy stems.
At 10 years, the Cemex bone cement tested performed just as well as the control (Palacos bone cement).
The Norwegian Arthroplasty Register, Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway. birgitte.espehaug@helse-bergen.no
Few studies have compared the long-term survival of cemented primary total hip arthroplasties (THAs), and several prostheses have been used without adequate knowledge of their endurance. We studied long-term outcome based on data in the Norwegian Arthroplasty Register.
The 10 most used prosthesis brands in 62,305 primary Palacos or Simplex cemented THAs reported to the Register from 1987 through 2007 were included. Survival analyses with revision as endpoint (for any cause or for aseptic loosening) were performed using Kaplan-Meier and multiple Cox regression with time-dependent covariates. Revision rate ratios (RRs) were estimated for the follow-up intervals: 0-5, 6-10, and > 10 years.
5 prosthesis brands (cup/stem combinations) (Charnley, Exeter, Titan, Spectron/ITH, Link IP/Lubinus SP; n = 24,728) were investigated with 0-20 year follow-up (inserted 1987-1997). After 18 years, 11% (95% CI: 10.6-12.1) were revised for any cause and 8.4% (7.7-9.1) for aseptic loosening. Beyond 10 years of follow-up, the Charnley cup had a lower revision rate due to aseptic loosening than Exeter (RR = 1.8) and Spectron (RR = 2.4) cups. For stems, beyond 10 years we did not find statistically significant differences comparing Charnley with Titan, ITH, and SP stems, but the Exeter stem had better results (RR = 05). 10 prosthesis brands (9 cups in combination with 6 stems; n = 37,577) were investigated with 0-10 years of follow-up (inserted from 1998 through 2007). The Charnley cup had a lower revision rate due to aseptic loosening than all cups except the IP. Beyond 5 years follow-up, the Reflection All-Poly cup had a 14 times higher revision rate. For stems, beyond 5 years the Spectron-EF (RR = 6.1) and Titan (RR = 5.5) stems had higher revision rates due to aseptic loosening than Charnley. The analyses also showed a marked improvement in Charnley results between the periods 1987-1997 and 1998-2007.
We observed clinically important differences between cemented prosthesis brands and identified inferior results for previously largely undocumented prostheses, including the commonly used prosthesis combination Reflection All-Poly/ Spectron-EF. The results were, however, satisfactory according to international standards.
Notes
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Loss of bone stock and stress shielding is a significant challenge in limb salvage surgery. This study investigates the adaptive bone remodeling of the femoral bone after implantation of a tumor prosthesis with an uncemented press fit stem. We performed a prospective 1 yr follow-up of 6 patients (mean age: 55 (26-78) yr, female/male=3/3) who underwent bone tumor resection surgery of the proximal femur (n=3) or distal femur (n=3). Reconstruction was done using a Global Modular Replacement System (Stryker® Orthopaedics, Mahwah, NJ) tumor prosthesis, and all patients received a straight-fluted 125-mm uncemented press-fit titanium alloy stem with hydroxyapatite coating of the proximal part of the stem. Measurements of bone mineral density (BMD; g/cm2) were done postoperatively and after 3, 6, and 12 mo in the part of the femur bone containing the Global Modular Replacement System stem using dual-energy X-ray absorptiometry. BMD was measured in 3 regions of interest (ROIs) in the femur bone. Nonparametric analysis of variance (Friedman test) for evaluation of changes in BMD over time. BMD decreased in all 3 ROIs with time. In ROI 1 (p=0.01), BMD decreased by 10% after 3 mo and ended with a total decrease of 14% after 1 yr. In ROI 2 (p=0.006), BMD was decreased by 6% after 3 and 6 mo; after 1 yr of follow-up, BMD was 9% below the postoperative value. In ROI 3 (p=0.009), BMD decreased by 6% after 3 and 6 mo; after 1 yr of follow-up, BMD was 8% below the postoperative value. A bone loss of 8%-9% during the first postoperative year was seen along the femoral stem, but in the bone containing the hydroxyapatite-coated part of the stem, the decrease in BMD was 14%, thus indicating that stress shielding of this part of the bone may play a role for the adaptive bone remodeling.
During the 10-year period 1981-90, 1752 primary total hip arthroplasties (THAs) were performed in the county of south Jutland, Denmark. The annual number of THA increased until a steady state level was reached during 1988-90. The age and sex specific incidences were calculated for this period using the population distribution of the County. The age specific incidences were highest in the age-group 70-79 years for both female and males, namely respectively 485 and 410 THAs per 100,000 inhabitants. The overall incidence was 82 THA per 100,000 inhabitants. During the next 30 years, the demand for primary THA in Denmark is expected to increase 32 percent (from 4013 to 5307 THAs) as a consequence of demographic changes.
OBJECTIVE: To investigate in a prospective study the relationship between age, pre-operative status, waiting time and post-operative outcome in patients assigned for unilateral total hip replacement (THR) due to osteoarthritis (OA). METHOD: One hundred and forty-eight patients (mean age 71 yr) with primary OA of the hip were investigated pre-operatively and 3, 6 and 12 months post-operatively with the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). For 56 of the patients an additional evaluation was made when they were placed on the waiting list. RESULTS: One hundred and twenty-four patients fulfilled the study criteria (age 50 yr or over and unilateral THR for OA during the study period). Before surgery there were no differences in the WOMAC or SF-36 subscales (except mental health) between patients aged over and under 72 yr. Post-operatively, the younger patients reached a better score than the older patients. There were no differences in pre-operative status or post-operative outcome between the patients who had been on the waiting list more than and less than 3 months. Most pain relief after hip replacement was obtained by 3 months, while it took at least 1 yr to reach the full benefit in improved function. Ninety per cent of the patients had improved by at least 10 points on a 100-point scale for pain and function at 12 months. CONCLUSION: The age of the patients assigned for THR did not determine their pre-operative status. However, younger patients gained more function post-operatively than older patients and reached higher absolute mean SF-36 values, except for pain. An average difference in time on the waiting list of 3 months did not result in a difference in post-operative outcome. At least 1 yr is required for the average OA patient to gain the full benefit of the THR.
In this prospective multicentre cohort study we studied subjects younger than 60 years of age scheduled for primary total hip arthroplasty (THA). The study assessed patients' overall satisfaction, fulfillment of preoperative expectations, the effect on socioeconomic parameters, and quality of sex-life. Questionnaires including Oxford Hip Score (OHS) and SF-36 were evaluated preoperatively and 3, 6 and 12 months postoperatively. OHS and SF-36 showed significant improvements (p
In order to assess the routine use of prophylactic antibiotics (AB) in arthroplastic surgery in Denmark, questionnaires were sent to all Danish orthopaedic departments and all general surgical departments that perform orthopaedic surgery. Fifty-six departments (93%) returned the questionnaires. All departments use prophylactic AB in primary knee and hip arthroplasty and in revision arthroplasty. In addition, all departments but one use prophylactic AB in arthroplasty secondary to osteosynthesis. The largest group of departments uses penicillinase-resistant penicillin (PRP) in their standard prophylaxis regimens. The second largest group uses second generation cephalosporins. With one exception, all use cefuroxime. A small group uses other types of AB. Fifteen percent of the departments combine systemic AB with gentamicin bone cement (GC) in primary hip arthroplasty, whereas 22% use this combination in primary knee arthroplasty. Significantly more departments use GC in revision arthroplasty (89%) and in arthroplasty secondary to osteosynthesis (63%). Prolonged antibiotic prophylaxis (beyond 24 hours) is practised to a significantly higher degree in revision arthroplastic surgery than in the primary arthroplasties. In conclusion, one of two homogeneous groups of prophylactic AB is used in arthroplastic surgery in Denmark as prescribed in the literature.
Antibiotic prophylaxis in total hip arthroplasty. Review of 10,905 primary cemented total hip replacements reported to the Norwegian arthroplasty register, 1987 to 1995.
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.