Background: Highly porous surfaces promoting biologic fixation have renewed interest in cementless total knee arthroplasty (TKA), but the potential for failed biologic fixation remains. The purpose of this study was to compare the clinical outcomes of cemented and cementless versions of the same TKA design at an average of 2 years postoperatively. Methods: This was an institutional review board-approved, prospective, randomized controlled trial of patients from 18 to 75 years of age who were undergoing a primary TKA. Patients with inflammatory arthritis, a body mass index (BMI) of >40 kg/m 2 , infection, a neuromuscular disorder, or grossly osteoporotic bone or bone defects were excluded. Patients were randomized to receive a cemented or cementless cruciate-retaining TKA of the same design. The cementless implant has highly porous fixation surfaces. Oxford Knee, Knee Society, and Forgotten Joint Scores were collected. Patients were asked to rate the knee with the TKA as a percentage of normal. Power analysis indicated that 130 patients were necessary to demonstrate a 5-point difference in the Oxford Knee Score at 90% power. Results: One hundred and forty-seven patients were enrolled, and 141 (96%) of them were analyzed at an average of 2 years postoperatively. There was no difference in age, sex, BMI, American Society of Anesthesiologists (ASA) score, or duration of follow-up (p = 0.1 to 0.9). There was also no difference in the change in the hemoglobin level from the preoperative measurement to postoperative day 1 between the 2 cohorts (mean and standard deviation, −2.6 ± 1.4 g/dL compared with −2.5 ± 0.9 g/dL, p = 0.5), but the total operative time was decreased in the cementless cohort (82.1 ± 16.6 compared with 93.7 ± 16.7 minutes, p = 0.001). There were no differences in any clinical outcome measure at 4 to 6 weeks, 1 year, or an average of 2 years postoperatively (p = 0.1 to 0.9) between the cemented and cementless cohorts. There was no radiographic evidence of component subsidence or loosening in either cohort. Conclusions: This study demonstrated that a recently introduced cementless TKA had results, both perioperatively and at an average of 2 years postoperatively, that were equivalent to those of its cemented predecessor, without any aseptic failures of either implant. Thus, this study justifies continued surveillance of this device to elucidate both its survivorship and if it can provide any long-term benefits. Level of Evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
Aims Modular dual mobility (DM) prostheses in which a cobalt-chromium liner is inserted into a titanium acetabular shell ( vs a monoblock acetabular component) have the advantage of allowing supplementary screw fixation, but the potential for corrosion between the liner and acetabulum has raised concerns. While DM prostheses have shown improved stability in patients deemed ‘high-risk’ for dislocation undergoing total hip arthroplasty (THA), their performance in young, active patients has not been reported. This study’s purpose was to assess clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) in young, active patients receiving a modular DM acetabulum and recently introduced titanium, proximally coated, tapered femoral stem design. Patients and Methods This was a prospective study of patients between 18 and 65 years of age, with a body mass index (BMI) < 35 kg/m2 and University of California at Los Angeles (UCLA) activity score > 6, who received a modular cobalt-chromium acetabular liner, highly crosslinked polyethylene mobile bearing, and cementless titanium femoral stem for their primary THA. Patients with a history of renal disease and metal hardware elsewhere in the body were excluded. A total of 43 patients (30 male, 13 female; mean age 52.6 years (sd 6.5)) were enrolled. All patients had a minimum of two years’ clinical follow-up. Patient-reported outcome measures, whole blood metal ion levels (ug/l), and periprosthetic femoral BMD were measured at baseline, as well as at one and two years postoperatively. Power analysis indicated 40 patients necessary to demonstrate a five-fold increase in cobalt levels from baseline (alpha = 0.05, beta = 0.80). A mixed model with repeated measures was used for statistical analysis. Results Mean Harris Hip Scores improved from 54.1 (sd 20.5) to 91.2 (sd 10.8) at two years postoperatively (p < 0.001). All patients had radiologically well-fixed components, no patients experienced any instability, and no patients required any further intervention. Mean cobalt levels increased from 0.065 ug/l (sd 0.03) preoperatively to 0.30 ug/l (sd 0.51) at one year postoperatively (p = 0.01) but decreased at two years postoperatively to 0.16 ug/l (sd 0.23; p = 0.2). Four patients (9.3%) had a cobalt level outside the reference range (0.03 ug/l to 0.29 ug/l) at two years postoperatively, with values from 0.32 ug/l to 0.94 ug/l. The mean femoral BMD ratio was maintained in Gruen zones 2 to 7 at both one and two years postoperatively using this stem design. At two years postoperatively, mean BMD in the medial calcar was 101.5% of the baseline value. Conclusion Use of a modular DM prosthesis and cementless, tapered femoral stem has shown encouraging results in young, active patients undergoing primary THA. Elevation in mean cobalt levels and the presence of four patients outside the reference range at two years postoperatively demonstrates the necessity of continued surveillance in this cohort. Cite this article: Bone Joint J 2019;101-B:365–371.
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