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Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures

NCT ID: NCT03903731

Last Updated: 2020-11-12

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

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-19

Study Completion Date

2019-08-08

Brief Summary

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Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.

Detailed Description

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Conditions

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Journey II BCS Total Knee System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Total knee arthroplasty with Journey II BCS Total Knee System

Journey II BCS Total Knee System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication;
* The TKA occurred at least 12 weeks prior to enrollment
* Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as well as ≥6 months post-enrollment.

Exclusion Criteria

* Subject received the JOURNEY II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael R. Dayton, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics, University of Colorado Denver

David J. Mayman, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Harold E. Cates, MD

Role: PRINCIPAL_INVESTIGATOR

Tennessee Orthopaedic Clinics

Hilde Vandenneucker, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Peter Black, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Anglesea Clinic Orthopaedics

Locations

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Department of Orthopaedics, University of Colorado Denver

Aurora, Colorado, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

Tennessee Orthopaedic Clinics

Knoxville, Tennessee, United States

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Anglesea Clinic Orthopaedics

Hamilton, , New Zealand

Site Status

Countries

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United States Belgium New Zealand

Other Identifiers

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16-4049-08B

Identifier Type: -

Identifier Source: org_study_id