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New treatment option for Knee Arthroplasty, Total
Official title Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
ClinicalTrials.gov ID: NCT05516381
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- people must meet all of the following to be included in the study:
- 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
You likely can't join if
- people will be excluded from the study if they meet any of the following exclusion criteria:
- 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
- people whose weight, age, or activity level might cause extreme loads and early failure of the system
See the full eligibility criteria
- people must meet all of the following to be included in the study:
- 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
- people will be excluded from the study if they meet any of the following exclusion criteria:
- 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
- people 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
- people with malignancy involving proximal tibia, distal femur, or knee joint
- people undergoing active administration of chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.