NCT02211794

Brief Summary

Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.

Trial Health

62
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
5 countries

5 active sites

Status
active not recruiting

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

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

12.4 years

First QC Date

July 22, 2014

Last Update Submit

January 29, 2024

Conditions

Degenerative Joint Disease

Keywords

Total Knee Arthroplastydegenerative joint disease

Outcome Measures

Primary Outcomes (1)

  • Revision for any reason

    The goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate of 94.3% (AOA annual report 201121) at 10 years. "Success" is defined as 10 year survival of the study device without revision for any reason.

    10Years

Secondary Outcomes (5)

  • EQ-5D questionnaire

    pre-op, 3month, 1yr, 2yr, 5yr, 10yr

  • Knee Pain Evaluation Form questionnaire

    3month, 1yr, 2yr

  • 2011 Knee Society Score

    pre-op, 3month, 1yr, 2yr, 5yr, 10yr

  • radiographic evaluation

    pre-op, discharge, 3month, 1yr, 5yr, 10yr

  • complication rate (adverse events and revisions)

    discharge, 3month, 1yr, 2yr, 5yr, 10yr

Study Arms (1)

1 cohort

subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)

Other: data collection

Interventions

data collectionOTHER
1 cohort

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

a patient population consisting of 150 cases and recruited from 4 different countries, will be followed up when undergoing TKA as part of their standard care

You may qualify if:

  • subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing
  • subject requires primary total knee arthroplasty due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)
  • subject is of legal age to consent, agrees to consent to and to follow the study visit schedule, by signing the EC approved informed consent form

You may not qualify if:

  • age \> 75 years
  • conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
  • subject has inadequate bone stock to support the device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UZ Gent

Ghent, 9000, Belgium

Location

University of Modena and Reggio Emilia

Modena, 41124, Italy

Location

Sint Maartenskliniek

Nijmegen, 9500, Netherlands

Location

Martina Hansens Hospital

Sandvika, Norway

Location

North Hampshire Hospital

Basingstoke, RG24 7AL, United Kingdom

Location

MeSH Terms

Conditions

Joint Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mike Risebury, MD

    North Hampshire Hospital

    PRINCIPAL INVESTIGATOR

  • Fabio Catani, Prof

    University of Modena and Reggio Emilia

    STUDY CHAIR

  • Jan Victor, Prof

    UZ Ghent

    PRINCIPAL INVESTIGATOR

  • Gijs Van Hellemondt

    Sint-Maartenskliniek Nijmegen

    PRINCIPAL INVESTIGATOR

  • Stig Heir

    Martina Hansens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2014

First Posted

August 7, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

BSI Publication

Locations

NL(1)BE(1)GB(1)IT(1)NO(1)