Minimum twelve-year follow-up of fixed- vs mobile-bearing total knee arthroplasty: Double blinded randomized trial

Abstract Background Total knee arthroplasty (TKA) with fixed-bearing (FB) implants have demonstrated impressive functional results and survival rates. Meanwhile, rotating-platform (RP) constructs have biomechanically shown to reduce polyethylene wear, lower the risk of component loosening, and better replicate anatomic knee motion. There is growing question of the clinical impact these design changes have long-term. Questions/purposes: The aim of this double-blinded prospective randomized trial was to compare function and implant survival in patients who received either FB or RP press-fit condylar Sigma (PFC Sigma, DePuy, Warsaw, IN) total knee replacements at a minimum follow-up of twelve years. Patients and methods Patient reported outcome measures used included the functional Knee Society Score, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores, Medical Outcomes Short Form-36 (SF-36) score, and satisfaction assessment on a four-point Likert scale. The data was collected from times preoperative, two-years, and final encounter (mean 13.95 years). A total of 28 RP and 19 FB knees (58.8%) were analyzed at the final follow-up. Results Among all patients, KSS and WOMAC scores statistically improved from pre-op to 2-year, while KSS statistically worsened from 2-year to final follow-up. The RP group averaged better follow-up scores in all assessments at the final follow-up with exception of overall satisfaction. There was no statistically significant difference in the functional Knee Society Score, Short Form-36, WOMAC scores, patient satisfaction or implant survival between the two groups at any measured period. Conclusions The use of a fixed-bearing or rotating-platform design does not convey significant superiority in terms of function or implant longevity at a minimum twelve years after total knee arthroplasty. Level of evidence Level I, Experimental study, randomized controlled trial (RCT).