Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
ConditionKnee Arthroplasty, Total
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorExactech
About this trial
The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.
Eligibility criteria
Qualifiers
Subject must be at least 18 years of age at the time of the surgery (skeletally mature)
Subject will receive a Optetrak Logic® CR device per the "Indications for Use" described above
Subject must be willing to comply with the pre-operative and post-operative visit requirements
Subject must be willing and able to provide written informed consent for participation in the study
Disqualifiers
Subject with a suspected or confirmed systemic infection and/or a secondary remote infection
Subject without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
Subject without sufficient soft tissue integrity to provide adequate stability
Subject with either mental or neuromuscular disorders that do not allow control of the knee joint
Trial design
Treatments tested in this trial
- Optetrak Logic CR Knee System
Treatment groups
148 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov