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Mechanical Alignment Versus Kinematic Alignment Total Knee Arthroplasty

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jun 30, 2027 → Jun 1, 2028
See other at-risk trials from Loyola University

Record History

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  1. Notable Primary and study completion pushed from Jun 30, 2027 to Jun 1, 2028
    • Start date: Mar 1, 2026 to Jan 1, 2027
    v4
  2. Notable Primary and study completion dates: Dec 31, 2024 to Jun 30, 2027
    • Start date: Sep 1, 2024 to Mar 1, 2026
    v3
  3. Notable Start date: Jul 1, 2024 to Sep 1, 2024
    • Primary endpoint revised
    • Secondary endpoint revised
    • Study description expanded, about 2 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06486714
Lead Sponsor Loyola University
Conditions
(from sponsor)
Knee Osteoarthritis
Related terms Osteoarthritis, Knee
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov