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ACTIVE NOT RECRUITING
NCT04600583
NA

A Trial of Mechanical Axis With Soft Tissue Release Balancing vs Functional Alignment With Bony Release Balancing in Total Knee Replacement Using Stryker's Mako Robot

Sponsor: Stryker South Pacific

View on ClinicalTrials.gov

Summary

This study is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. All patients will be treated with the same knee system, implanted using MAKO robotic-arm assisted technology.

Official title: A Prospective, Randomized, Controlled Trial of Mechanical Axis With Soft Tissue Release Balancing vs Functional Alignment With Bony Release Balancing in Total Knee Replacement - A Study Using Stryker Mako Robotic-Arm Assisted Technology®.

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

278

Start Date

2020-11-12

Completion Date

2025-03

Last Updated

2024-07-23

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA)

All patients, regardless of the alignment arm they are randomized to will undergo a primary total knee arthroplasty with the Triathlon® Total Knee System using Mako Robotic-Arm Assisted Technology. The surgical intervention will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours.

Locations (1)

North Shore Hospital

Takapuna, Auckland, New Zealand