Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-25 @ 5:49 AM
Study NCT ID:
NCT02539992
Status:
TERMINATED
Last Update Posted:
2024-02-22
First Post:
2015-09-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ShapeMatch Cutting Guide Functional Outcomes Study
Sponsor:
Stryker Orthopaedics
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Multi-centre Study of the Triathlon Cruciate Retaining Total Knee System Using ShapeMatch Cutting Guides
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Product discontinued in November 2014
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ShapeMatch
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: