Journey II BCS EU Observational Trial

Smith & Nephew

Status: Active, not recruiting

Conditions: Degenerative Joint Disease

Treatments: Other: data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT02211794

R11009-7

Details and patient eligibility

About

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

Full 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.

Enrollment: 175 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

175 participants in 1 patient group

1 cohort

Description:

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)

Treatment:

Other: data collection