Clinical Trial

Mechanical Alignment Versus Kinematic Alignment Total Knee Arthroplasty

Not Yet Recruiting
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Summary
Historically, total knee arthroplasty (TKA) has been performed with the goal of restoring a neutral mechanical axis, eliminating the average 3 degrees of valgus and varus of the distal femur and proximal tibia joint lines respectively. This is thought to provide a more stable and neutral joint-bearing surface. Because of this shift to a 0-degree knee angle, soft tissue releases are frequently required to balance the knee after making the distal tibia and proximal tibia cuts. More recently and increasingly, TKAs have been performed with a goal of restoring kinematic, or anatomic, alignment of the knee. This is thought to provide a more normal native knee angle, with the hopes of precluding the necessity of soft tissue releases to balance the knee. While some studies are promising regarding kinematically aligned TKAs (KA-TKA), at present, it is unclear how these compare to mechanically aligned TKAs (MA-TKA) in terms of patient reported outcome measures (PROM) when compared head-to-head. This study will randomize patients to receive either cemented MA-TKA or KA-TKA with the goal of assessing pain scores and PROMs at various time points following surgery.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-06-27; most recent amendment 2025-12-02.
Trial Details
NCT Number NCT06486714
Lead Sponsor Loyola University
Conditions Knee Osteoarthritis
Enrollment 96 participants
Start Date 2026-03-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-09