Mechanical Alignment Versus Kinematic Alignment Total Knee Arthroplasty

Sponsor
Loyola University
Study ID
NCT06486714
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 3, 2024
Start date
Jan 1, 2027
Status verified
Aug 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Kinematic Total Knee Arthroplasty
    KA-TKAs recreate the native joint line, hip-knee-ankle angle, and rotation of the pre-arthritic joint.
  • Active Comparator: Mechanical Total Knee Arthroplasty
    MA-TKAs are performed by which the distal femur and proximal tibia cuts are made perpendicular to the mechanical axis, a line connecting the center of the femoral head to the center of the ankle. These cuts are classically described as a 6-degree valgus cut of the distal femur and a 0-degree cut of the proximal tibia in relation to the mechanical axis. MA-TKAs create a 0-degree hip-knee-ankle angle.

Primary Outcome Measure

Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr Score [ Time Frame: Baseline, 2 weeks post op, 6 weeks post op, 1 week post op ]

Central Contacts

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