Randomized controlled trial comparing traditional versus enhanced-fixation designs of a novel cemented total knee arthroplasty tibial component.

Aims: A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis.

Methods: Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits.

Results: The patient cohort mean age was 66 years (SD seven years), 59% were female, and the mean BMI was 32 kg/m (SD 6 kg/m). Mean two-year subsidence of the EF-TKA was 0.056 mm (95% confidence interval (CI) 0.025 to 0.086) versus 0.006 mm (95% CI -0.029 to 0.040) for the Std-TKA, and the two-year maximum total point motion (MTPM) was 0.285 mm (95% upper confidence limit (UCL) ≤ 0.363) versus 0.346 mm (95% UCL ≤ 0.432), respectively, for a mean difference of -0.061 mm (95% CI -0.196 to 0.074). Inducible displacement also did not differ between groups. The MTPMs between 12 and 24 months for each group was below the published threshold of 0.2 mm for predicting early aseptic loosening (p < 0.001 and p = 0.001, respectively).

Conclusion: Both the enhanced fixation and the standard tibial implant design showed fixation with a predicted low risk of long-term aseptic loosening.