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

NCT05516381 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2024-06-18

No results posted yet for this study

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.

Conditions

  • Knee Arthroplasty, Total

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.

Sponsors & Collaborators

  • Exactech

    lead INDUSTRY

Principal Investigators

  • David Mateu-Vincent, Medical Degree · Orthpaedic Surgeon Hospital Universitaria Mutua Terrassa

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516381 on ClinicalTrials.gov