NCT02527148

A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement

A Prospective, Randomized, Controlled Trial of Mechanical Axis vs Kinematic Alignment in TKR - With a Follow-up, Longitudinal Study of the Clinical and Radiographic Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Stryker South Pacific · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. In this study ShapeMatch® cutting guides will be compared to the conventional approach.

Conditions

• Arthroplasties
• Knee Replacement

Interventions

Type	Name	Description
DEVICE	OtisMed® ShapeMatch® Technology	The appropriate Stryker ShapeMatch® Cutting Guides will be used to guide the surgeons bone resections. The surgeon will implant the knee prostheses following the surgical protocol for Triathlon® Knee System with OtisMed® ShapeMatch® Technology
DEVICE	Stryker Precision Knee Navigation	Stryker PrecisioN Knee (4.0) Navigation System, comprising of computer hardware and software and associated instrumentation, will be used for intra-operative alignment and orientation of implant. Navigation trackers will be secured to the femur and tibia and registration of the limb will be undertaken according to the PrecisioN Knee System surgical technique.Femoral and tibial resections, followed by device implantation, will be performed according to the Triathlon Knee System Surgical Protocol.
PROCEDURE	Total Knee Replacement
DEVICE	Stryker Triathlon® Total Knee System	Prosthetic components to be implanted including * Triathlon® Cruciate Retaining (CR) Total Knee System (cemented), including Femoral Component and Primary Tibial Baseplate; * Triathlon® Cruciate Substituting (CS) X3® polyethylene insert; * Triathlon® X3 Patella (asymmetric) - treated selectively by surgeon.

Timeline

• Start date: 2011-08-04
• Primary completion: 2018-04-09
• Completion: 2018-12-19
• First posted: 2015-08-18
• Last updated: 2025-05-15
• Results posted: 2016-01-12