Journey II BCS EU Observational Trial

Active, not recruiting

• Conditions: Degenerative Joint Disease
• Interventions: Other: data collection

• Registration Number: NCT02211794
• Lead Sponsor: Smith & Nephew Orthopaedics AG

Brief Summary

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

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1 cohort	data collection	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)

Primary Outcome Measures

Name	Time	Method
Revision for any reason	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 Outcome Measures

Name	Time	Method
complication rate (adverse events and revisions)	discharge, 3month, 1yr, 2yr, 5yr, 10yr	complications will be assessed at each visit.
2011 Knee Society Score	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
radiographic evaluation	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.
EQ-5D questionnaire	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)
Knee Pain Evaluation Form questionnaire	3month, 1yr, 2yr	Assessment of post-operative knee pain

Trial Locations

Locations (5)

UZ Gent; 🇧🇪 Gent, Belgium

North Hampshire Hospital; 🇬🇧 Basingstoke, United Kingdom

University of Modena and Reggio Emilia; 🇮🇹 Modena, Italy

Martina Hansens Hospital; 🇳🇴 Sandvika, Norway

Sint Maartenskliniek; 🇳🇱 Nijmegen, Netherlands