NCT02539992

ShapeMatch Cutting Guide Functional Outcomes Study

A Prospective, Randomized, Multi-centre Study of the Triathlon Cruciate Retaining Total Knee System Using ShapeMatch Cutting Guides

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria.

Detailed description

This study will be a prospective, randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria. Forty-eight cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Another forty-eight cases enrolled will receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. And the last forty-eight cases will receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment.

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DEVICE	Triathlon® CR/Kinematic Alignment	Total knee replacement using patient-specific cutting guides
DEVICE	Triathlon® CR/Neutral Overall Limb Alignment	Total knee replacement using patient-specific cutting guides
DEVICE	Triathlon® CR/Conventional Limb Alignment	Total knee replacement using traditional instrumentation

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-09-03
• Last updated: 2024-02-22
• Results posted: 2016-05-16

Locations

4 sites across 3 countries: Germany, Italy, United Kingdom