Journey II BCS EU Observational Trial

Degenerative Joint Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02211794
• Other study ID #: R11009-7
• Status: Active, not recruiting
• Start date: January 2014
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Other:
• data collection

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Italy	University of Modena and Reggio Emilia	Modena
Netherlands	Sint Maartenskliniek	Nijmegen
Norway	Martina Hansens Hospital	Sandvika
United Kingdom	North Hampshire Hospital	Basingstoke

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Knee Pain Evaluation Form questionnaire	Assessment of post-operative knee pain	3month, 1yr, 2yr
Secondary	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
Secondary	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
Secondary	complication rate (adverse events and revisions)	complications will be assessed at each visit.	discharge, 3month, 1yr, 2yr, 5yr, 10yr