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RECRUITING
NCT05516381
NA

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

Sponsor: Exactech

View on ClinicalTrials.gov

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.

Official title: Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2023-05-15

Completion Date

2027-06

Last Updated

2024-06-18

Healthy Volunteers

Yes

Interventions

DEVICE

Optetrak Logic CR Knee System

The OPTETRAK® Comprehensive Knee System consists of the OPTETRAK® Total Knee System and the OPTETRAK Logic® Total Knee System. The OPTETRAK Comprehensive Knee System comprises both non-porous and porous knee prostheses for use in total-knee joint replacement procedures. (In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.) The system includes various sizes and types of modular femoral components, tibial components, patellar components, and accessories for use in primary and revision applications.

Locations (1)

Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C.

Barcelona, Spain