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Mechanical Alignment Versus Kinematic Alignment Total Knee Arthroplasty

NCT06486714 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-12-09

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Total knee arthroplasty

All patients indicated for primary total knee arthroplasty will receive a cruciate-retaining cemented or cementless implant system, utilizing either MA or KA methodology.

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Nicholas Brown, MD · Loyola University Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-06-30
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06486714 on ClinicalTrials.gov