Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS)

NCT ID: NCT03885531

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

586 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-27

Study Completion Date

2020-06-30

Brief Summary

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The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.

Detailed Description

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Conditions

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Journey II CR Total Knee System

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Total knee arthroplasty with Journey II CR Total Knee System

TKA with Journey II CR Total Knee System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an approved indication;
* The TKA occurred at least 12 weeks prior to enrollment

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nor Consult

UNKNOWN

Sponsor Role collaborator

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra Navarrete

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Locations

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Orthopaedic Specialists of Scottsdale

Scottsdale, Arizona, United States

Site Status

Pikeville Medical Center

Pikeville, Kentucky, United States

Site Status

Reno Orthopedic Institute

Reno, Nevada, United States

Site Status

New York University

New York, New York, United States

Site Status

OrthoNeuro

New Albany, Ohio, United States

Site Status

Tennessee Orthopaedic Clinics

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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2018.19.KNE.JIICR.RET

Identifier Type: -

Identifier Source: org_study_id

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