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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Total knee arthroplasty
Procedure/SurgeryAll 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Other outcomes
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.
Forgotten Joint Score
The Forgotten Joint Score is a patient-reported outcome measure, scaled from 0-100, with higher scores meaning improved outcomes.
Pain Visual Analogue Scale
Pain scale scaled from 0-10 with higher scores indicating more pain.
Range of motion
Range of motion defined as degrees of knee extension and flexion
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: