Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study
Exactech
148 participants
May 15, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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
Exclusion Criteria12
- 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
- Subjects whose weight, age, or activity level might cause extreme loads and early failure of the system
- Subject is participating in another drug or device study other than knee replacement within the last three (3) months
- Subject has behavioral and/or mental issues that may interfere with their ability to follow post-operative instructions
- Subject is a prisoner
- Subject is pregnant
- Subject is undergoing radiation therapy where the targeted field involves the knee joint
- Subjects with malignancy involving proximal tibia, distal femur, or knee joint
- Subjects undergoing active administration of chemotherapy
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Interventions
The OPTETRAK® Comprehensive Knee System consists of the OPTETRAK® Total Knee System and the OPTETRAK Logic® Total Knee System. The OPTETRAK Comprehensive Knee System comprises both non-porous and porous knee prostheses for use in total-knee joint replacement procedures. (In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.) The system includes various sizes and types of modular femoral components, tibial components, patellar components, and accessories for use in primary and revision applications.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05516381