Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• Subjects must meet all of the following inclusion criteria 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
Locations
Other Locations
Spain
Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C.
RECRUITING
Barcelona
Contact Information
Primary
Alex Knisely, BSBA
alex.knisely@exac.com
352-474-9582
Backup
Amanda Ford, PhD
amanda.ford@exac.com
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2027-06
Participants
Target number of participants: 148
Treatments
Other: Restricted Invers Kinematic Knee Alignment Technique
Restricted Invers Kinematic Knee Alignment Technique
Other: Mechanical Knee Alignment Technique
Mechanical Knee Alignment Technique
Related Therapeutic Areas
Sponsors
Leads: Exactech