NCT03292003

Brief Summary

The objective of this study is to estimate the safety and performance of Journey II BCS TKS.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,694

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

May 20, 2017

Last Update Submit

March 27, 2019

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

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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Colorado Orthopaedics

Aurora, Colorado, 80045, United States

Location

Andrews Research and Education Foundation

Gulf Breeze, Florida, 32571, United States

Location

Methodist Sports Medicine

Indianapolis, Indiana, 46280, United States

Location

Hospital for Special Surgery

New York, New York, United States

Location

University Orthopaedics Center

State College, Pennsylvania, 16602, United States

Location

TN Orthopaedic Foundation for Education and Research

Knoxville, Tennessee, 37923, United States

Location

San Antonio Orthopaedic Specialists

San Antonio, Texas, 78258, United States

Location

Providence Regional Medical Center

Everett, Washington, 98021, United States

Location

Marra Knee and Shoulder Center

Wheeling, West Virginia, 26003, United States

Location

Jesse Ziekenhuis

Hasselt, Belgium

Location

UZ Leuven Campus

Pellenberg, Belgium

Location

Christen Ortho AG

Bern, Switzerland

Location

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

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

Primary Completion

January 30, 2018

Study Completion

September 24, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(9)BE(2)CH(1)