No Difference in 10-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Trial.

Background: There is continuing debate about the ideal philosophy for component alignment in TKA. However, there are limited long-term functional and radiographic data on randomized comparisons of kinematic alignment versus mechanical alignment.

Questions/purposes: We present the 10-year follow-up findings of a single-center, multisurgeon randomized controlled trial (RCT) comparing these two alignment philosophies in terms of the following questions: (1) Is there a difference in PROM scores? (2) Is there a difference in survivorship free from revision or reoperation for any cause? (3) Is there a difference in survivorship free from radiographic loosening?

Methods: Ninety-nine patients undergoing primary TKA for osteoarthritis were randomized to either the mechanical alignment (n = 50) or kinematic alignment (n = 49) group. Eligibility for the study was patients undergoing unilateral TKA for osteoarthritis who were suitable for a cruciate-retaining TKA and could undergo MRI. Patients who had previous osteotomy, coronal alignment > 15° from neutral, a fixed flexion deformity > 15°, or instability whereby constrained components were being considered were excluded. Computer navigation was used in the mechanical alignment group, and patient-specific cutting blocks were used in the kinematic alignment group. At 10 years, 86% (43) of the patients in the mechanical alignment group and 80% (39) in the kinematic alignment group were available for follow-up performed as a per-protocol analysis. The PROMs that we assessed included the Knee Society Score, Oxford Knee Score, WOMAC, Forgotten Joint Score, and EuroQol 5-Dimension score. Kaplan-Meier analysis was used to assess survivorship free from reoperation (any reason) and revision (change or addition of any component). A single blinded observer assessed radiographs for signs of aseptic loosening (as defined by the presence of progressive radiolucent lines in two or more zones), which was reported as survivorship free from loosening.

Results: At 10 years, there was no difference in any PROM score measured between the groups. Ten-year survivorship free from revision (components removed or added) likewise did not differ between the groups (96% [95% CI 91% to 99%] for the mechanical alignment group and 91% [95% CI 83% to 99%] for the kinematic alignment group; p = 0.38). There were two revisions in the mechanical alignment group (periprosthetic fracture, deep infection) and four in the kinematic alignment group (two secondary patella resurfacings, two deep infections). There was no statistically significant difference in reoperations for any cause between the two groups. There was no difference with regard to survivorship free from loosening on radiographic review (χ2 = 1.3; p = 0.52) (progressive radiolucent lines seen at 10 years were 0% for mechanical alignment and 3% for kinematic alignment).

Conclusion: Like the 2-year and 5-year outcomes previously reported, 10-year follow-up for this RCT demonstrated no functional or radiographic difference in outcomes between mechanical alignment and kinematic alignment TKA. Anticipated functional benefits of kinematic alignment were not demonstrated, and revision-free survivorship at 10 years did not differ between the two groups. Given the unknown long-term impact of kinematic alignment with regard to implant position (especially tibial component varus), we must conclude that mechanical alignment remains the reference standard for TKA. We could not demonstrate any advantage to kinematic alignment at 10-year follow-up.

Level of evidence: Level I, therapeutic study.