Mechanical Alignment Versus Kinematic Alignment Total Knee Arthroplasty

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoyola University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients 18 years or older presenting to our institutions indicated for a primary total knee arthroplasty

Disqualifiers

Revision TKA

Patients with prior injuries to study knee

Patients with history of childhood knee disease

Patients who cannot complete questionnaires in English

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total knee arthroplasty

    Procedure/Surgery

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

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Kinematic Total Knee ArthroplastyExperimental treatment 1 intervention
Group B: Mechanical Total Knee ArthroplastyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr Score

The KOOS Jr Score is a patient-reported outcome measure, scaled from 0-28, with higher scores meaning worse outcomes.

Time frame
Baseline, 2 weeks post op, 6 weeks post op, 1 week post op

Secondary outcomes

1

Patient Reported Outcome Measure Information System (PROMIS) Physical Function

The PROMIS Physical Function Score is a patient-reported outcome measure, scaled from 0-20, with higher scores meaning improved outcomes.

Time frame
Baseline, 2 weeks post op, 6 weeks post op, 1 week post op

Other outcomes

1

Patient Reported Outcome Measure Information System (PROMIS) Pain Interference

The PROMIS Pain Interference Score is a patient-reported outcome measure, scaled from 0-20, with higher scores meaning worse pain.

Time frame
Baseline, 2 weeks post op, 6 weeks post op, 1 week post op
2

Forgotten Joint Score

The Forgotten Joint Score is a patient-reported outcome measure, scaled from 0-100, with higher scores meaning improved outcomes.

Time frame
Baseline, 2 weeks post op, 6 weeks post op, 1 week post op
3

Pain Visual Analogue Scale

Pain scale scaled from 0-10 with higher scores indicating more pain.

Time frame
Baseline, 2 weeks post op, 6 weeks post op, 1 week post op
4

Range of motion

Range of motion defined as degrees of knee extension and flexion

Time frame
Baseline, 2 weeks post op, 6 weeks post op, 1 week post op

Locations

This trial has no locations.

Sponsors and contacts

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