Actively Recruiting
Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
Led by Exactech · Updated on 2024-06-18
148
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must be at least 18 years of age at the time of the surgery (skeletally mature)
- Subject will receive a Optetrak Logic4 CR device per the indications for use
- Subject must be willing to comply with pre-operative and post-operative visit requirements
- Subject must be willing and able to provide written informed consent for participation in the study
You will not qualify if you...
- 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 mental or neuromuscular disorders that prevent 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 3 months
- Subject has behavioral or mental issues interfering with ability to follow post-operative instructions
- Subject is a prisoner
- Subject is pregnant
- Subject is undergoing radiation therapy involving the knee joint
- Subjects with malignancy involving proximal tibia, distal femur, or knee joint
- Subjects undergoing active chemotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C.
Barcelona, Spain
Actively Recruiting
Research Team
A
Alex Knisely, BSBA
CONTACT
A
Amanda Ford, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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