NCT04600583

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

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®.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Stryker South Pacific · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-12
• Primary completion: 2023-12-20
• Completion: 2025-03-01
• First posted: 2020-10-23
• Last updated: 2024-07-23

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated device study