NCT02516163

Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using Shapematch Cutting Guides:Sub-Study A

A Prospective, Non-randomized,Study of the Clinical Outcomes of Participants That Receive the Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study A

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Stryker South Pacific · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-randomized, study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.

Detailed description

This is a prospective, non-randomized, study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides. Sub-study A aims to quantify the reproducibility of intra-operatively positioning the cutting guides onto the affected femoral and tibial joint surfaces.

Conditions

• Arthroplasties, Replacement, Knee

Interventions

Type	Name	Description
DEVICE	Shapematch Cutting Guides	Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and associated instruments. No post-operative evaluations will be undertaken as part of this sub-study

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2015-08-05
• Last updated: 2016-01-12
• Results posted: 2016-01-12