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

NCT02527148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-15

Study results available
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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

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.

Sponsors & Collaborators

  • Stryker South Pacific

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-04
Primary Completion
2018-04-09
Completion
2018-12-19

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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 NCT02527148 on ClinicalTrials.gov