Trials Sponsors Conditions Drugs Pricing

Conditions

Total Knee Arthroplasty

Keywords

rheumatoid arthritispost-traumatic arthritisosteoarthritisdegenerative arthritisfailed osteotomy

Outcome Measures

Primary Outcomes (1)

Revision Rate of Total Knee System
Number of revisions
implantation through study completion, approximately 3 years

Secondary Outcomes (10)

Adverse Events
implantation through study completion, approximately 3 years
Health care utilization: Hospitalization
implantation through study completion, approximately 3 years
Health care utilization: Hospitalization
implantation through study completion, approximately 3 years
Health care utilization: Rehabilitation
implantation through study completion, approximately 3 years
Health care utilization: Outpatient visits
implantation through study completion, approximately 3 years
+5 more secondary outcomes

Study Arms (1)

Journey II BCS Total Knee System

Subjects having TKA with Journey II BCS Total Knee System

Device: Journey II BCS Total Knee System

Interventions

Journey II BCS Total Knee SystemDevice

Journey II BCS Total Knee System

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Sites will identify potential subjects by retrospectively reviewing their source documents in order to identify all patients who received TKA with the Journey II BCS TKS.

You may qualify if:

Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication

Sponsors & Collaborators

Smith & Nephew, Inc.
Industrylead

Study Sites (12)

University of Colorado Orthopaedics

Aurora, Colorado, 80045, United States

Andrews Research and Education Foundation

Gulf Breeze, Florida, 32571, United States

Methodist Sports Medicine

Indianapolis, Indiana, 46280, United States

Hospital for Special Surgery

New York, New York, United States

University Orthopaedics Center

State College, Pennsylvania, 16602, United States

TN Orthopaedic Foundation for Education and Research

Knoxville, Tennessee, 37923, United States

San Antonio Orthopaedic Specialists

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Beate Hanson, MD, PhD
Vice President, Global Clinical Strategy
STUDY CHAIR

Enrollment

1,694 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: RETROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 20, 2017

First Posted

September 25, 2017

Study Start

December 30, 2016

Actual (reported)

Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

Journey II BCS Total Knee System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

Journey II BCS Total Knee System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations