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Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment

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

Clinical Trial 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.

Clinical Trial Description

A prospective randomized clinical study will be conducted. The study will consist of two cohorts and will collect clinical data from a maximum of 148 knee arthroplasty surgeries during which the patient will receive the Optetrak Logic® CR TKA device. Cohorts will consist of 1) subjects undergoing MA TKA and 2) subjects undergoing restricted iKA TKA. All cohorts will utilize navigation-assisted surgery (ExactechGPS®) and will be enrolled and consented concurrently. Subjects will be randomized and have a 50% chance of being assigned to the MA TKA cohort and a 50% chance of being assigned to the restricted iKA TKA cohort. Study and research staff will be blinded to randomization and the cohort allocation until after consenting and eligibility is determined. Subjects will be blinded to the randomization (MA TKA or restricted iKA TKA) until the completion of the study. Data collection under this protocol shall be conducted in a way that conforms to any applicable local and national rules, regulations, and guidelines relating to the conduct of clinical research and the protection of human subjects. As appropriate, this may include but is not limited to the following: Good Clinical Practice (GCP) requirements, FDA regulations and guidelines, ISO 14155: 2020, ICH guidelines, HIPAA and other regulations pertaining to the protection of patient data and data privacy, guidelines established by local Institutional Review Boards or similar Ethics Committees, the Belmont Report, and the Declaration of Helsinki. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05516381
Study type Interventional
Source Exactech
Contact Alex Knisely, BSBA
Phone 352-474-9582
Email alex.knisely@exac.com
Status Recruiting
Phase N/A
Start date May 15, 2023
Completion date June 2027
View Details
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