Knee Arthroplasty, Total Clinical Trial
Official title:
Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study
NCT number | NCT05516381 |
Other study ID # | TM-2021-1586 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2023 |
Est. completion date | June 2027 |
Verified date | June 2024 |
Source | Exactech |
Contact | Alex Knisely, BSBA |
Phone | 352-474-9582 |
alex.knisely[@]exac.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 148 |
Est. completion date | June 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C. | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Exactech |
Spain,
Almaawi AM, Hutt JRB, Masse V, Lavigne M, Vendittoli PA. The Impact of Mechanical and Restricted Kinematic Alignment on Knee Anatomy in Total Knee Arthroplasty. J Arthroplasty. 2017 Jul;32(7):2133-2140. doi: 10.1016/j.arth.2017.02.028. Epub 2017 Feb 20. — View Citation
Winnock de Grave P, Luyckx T, Claeys K, Tampere T, Kellens J, Muller J, Gunst P. Higher satisfaction after total knee arthroplasty using restricted inverse kinematic alignment compared to adjusted mechanical alignment. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):488-499. doi: 10.1007/s00167-020-06165-4. Epub 2020 Jul 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Society Score (KSS) | Validated outcome score | 3-month | |
Primary | Knee Society Score (KSS) | Validated outcome score | 6-month | |
Primary | Knee Society Score (KSS) | Validated outcome score | 12-month | |
Primary | Forgotten Joint Score (FJS) | Validated outcome score | 3-month | |
Primary | Forgotten Joint Score (FJS) | Validated outcome score | 6-month | |
Primary | Forgotten Joint Score (FJS) | Validated outcome score | 12-month | |
Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Validated outcome score | 3-month | |
Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Validated outcome score | 6-month | |
Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Validated outcome score | 12-month | |
Primary | Visual Analog Scale (VAS) - Pain | Visual scale from 1-10 (low score is better) | 3-month | |
Primary | Visual Analog Scale (VAS) - Pain | Visual scale from 1-10 (low score is better) | 6-month | |
Primary | Visual Analog Scale (VAS) - Pain | Visual scale from 1-10 (low score is better) | 12-month | |
Primary | Visual Analog Scale (VAS) - Patient Satisfaction | Visual scale from 1-10 (high score is better) | 3-month | |
Primary | Visual Analog Scale (VAS) - Patient Satisfaction | Visual scale from 1-10 (high score is better) | 6-month | |
Primary | Visual Analog Scale (VAS) - Patient Satisfaction | Visual scale from 1-10 (high score is better) | 12-month | |
Secondary | Knee Alignment | Characterization of knee in terms of ligament balancing will be assessed through constant-pressure full arc of motion measurement. | Intraoperative |
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