NCT02527161

Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B

A Prospective, Non-randomized, Longitudinal 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 B

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Stryker South Pacific · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-randomized, longitudinal study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. This sub-study involved the assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and post-operatively. An assessment of post-operative patient outcomes compared to pre-operative status was also analysed.

Detailed description

Protocol Attached in documentation.

Conditions

• Arthroplasties, Replacement, Knee

Interventions

Type	Name	Description
DEVICE	ShapeMatch Cutting Guides with Triathlon	All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-11-01
• Completion: 2018-04-01
• First posted: 2015-08-18
• Last updated: 2020-09-18
• Results posted: 2015-10-28