Journey II BCS EU Observational Trial

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Joint Disease
• Intervention / Treatment: Other: data collection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • UZ Gent
• Italy
  • Modena, Italy, 41124
    • University of Modena and Reggio Emilia
• Netherlands
  • Nijmegen, Netherlands, 9500
    • Sint Maartenskliniek
• Norway
  • Sandvika, Norway
    • Martina Hansens Hospital
• United Kingdom
  • Basingstoke, United Kingdom, RG24 7AL
    • North Hampshire Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D questionnaire	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)	pre-op, 3month, 1yr, 2yr, 5yr, 10yr
Knee Pain Evaluation Form questionnaire	Assessment of post-operative knee pain	3month, 1yr, 2yr
2011 Knee Society Score	A clinical follow-up and patient satisfaction, patient's expectations and a self-assessment of the physical outcome	pre-op, 3month, 1yr, 2yr, 5yr, 10yr
radiographic evaluation	The Knee Society Total Knee Arthroplasty Roentographic Evaluation and Scoring System will be used to analyse radiographic findings at each visit.	pre-op, discharge, 3month, 1yr, 5yr, 10yr
complication rate (adverse events and revisions)	complications will be assessed at each visit.	discharge, 3month, 1yr, 2yr, 5yr, 10yr

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Principal Investigator: Mike Risebury, MD, North Hampshire Hospital; Study Chair: Fabio Catani, Prof, University of Modena and Reggio Emilia; Principal Investigator: Jan Victor, Prof, UZ Ghent; Principal Investigator: Gijs Van Hellemondt, Sint-Maartenskliniek Nijmegen; Principal Investigator: Stig Heir, Martina Hansens Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimated): August 7, 2014

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; degenerative joint disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: R11009-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BSI Publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No