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NCT Number: NCT02211794

Journey II BCS EU Observational Trial

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Degenerative Joint Disease Joint Diseases Musculoskeletal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Gent, Ghent, Belgium

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About this study

Multicenter, prospective, observational study to collect relevant clinical data from 167 subjects implanted with the Journey II BCS Knee System. Data from eligible subjects, who have provided written informed consent for the collection of their coded data will be recorded from the patient's medical file on specially designed case report forms (CRF's).

Total study duration for participants will be 10 years with follow-up visits planned at 3 months, 1 year, 2 years, 5 years and 10 years post-surgery. An interim analysis describing the clinical outcome is planned after 5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Data Collection

Other

Primary outcomes

  1. Revision for any reason

    Time frame: 10Years

    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.

Secondary outcomes

  1. EQ-5D questionnaire

    Time frame: pre-op, 3month, 1yr, 2yr, 5yr, 10yr

    patient's opinion about his state of health, according to a visual analogue scale and 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression, (each dimension having 3 levels: no problems, some problems, extreme problems)

  2. Knee Pain Evaluation Form questionnaire

    Time frame: 3month, 1yr, 2yr

    Assessment of post-operative knee pain

  3. 2011 Knee Society Score

    Time frame: pre-op, 3month, 1yr, 2yr, 5yr, 10yr

    A clinical follow-up and patient satisfaction, patient's expectations and a self-assessment of the physical outcome

  4. radiographic evaluation

    Time frame: pre-op, discharge, 3month, 1yr, 5yr, 10yr

    The Knee Society Total Knee Arthroplasty Roentographic Evaluation and Scoring System will be used to analyse radiographic findings at each visit.

  5. complication rate (adverse events and revisions)

    Time frame: discharge, 3month, 1yr, 2yr, 5yr, 10yr

    complications will be assessed at each visit.

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Official study title

A Prospective, Non-randomized, Consecutive Series, Multicenter, Observational Trial to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2014
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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