NCT05516381 Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
| NCT ID | NCT05516381 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Exactech |
| Condition | Knee Arthroplasty, Total |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2023-05-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 148 participants in total. It began in 2023-05-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Subjects must meet all of the following inclusion criteria to be included in the study: 1. Subject must be at least 18 years of age at the time of the surgery (skeletally mature) 2. Subject will receive a Optetrak Logic® CR device per the "Indications for Use" described above 3. Subject must be willing to comply with the pre-operative and post-operative visit requirements 4. Subject must be willing and able to provide written informed consent for participation in the study Exclusion Criteria: * Subjects will be excluded from the study if they meet any of the following exclusion criteria: 1. Subject with a suspected or confirmed systemic infection and/or a secondary remote infection 2. Subject without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis 3. Subject without sufficient soft tissue integrity to provide adequate stability 4. Subject with either mental or neuromuscular disorders that do not allow control of the knee joint 5. Subjects whose weight, age, or activity level might cause extreme loads and early failure of the system 6. Subject is participating in another drug or device study other than knee replacement within the last three (3) months 7. Subject has behavioral and/or mental issues that may interfere with their ability to follow post-operative instructions 8. Subject is a prisoner 9. Subject is pregnant 10. Subject is undergoing radiation therapy where the targeted field involves the knee joint 11. Subjects with malignancy involving proximal tibia, distal femur, or knee joint 12. Subjects undergoing active administration of chemotherapy
Contact & Investigator
David Mateu-Vincent, Medical Degree
PRINCIPAL INVESTIGATOR
Orthpaedic Surgeon Hospital Universitaria Mutua Terrassa
Frequently Asked Questions
Who can join the NCT05516381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Arthroplasty, Total. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05516381 currently recruiting?
Yes, NCT05516381 is actively recruiting participants. Contact the research team at alex.knisely@exac.com for enrollment information.
Where is the NCT05516381 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT05516381 clinical trial?
NCT05516381 is sponsored by Exactech. The principal investigator is David Mateu-Vincent, Medical Degree at Orthpaedic Surgeon Hospital Universitaria Mutua Terrassa. The trial plans to enroll 148 participants.