Journey II BCS EU Observational Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2026-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Degenerative Joint Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

data collection

Intervention Type OTHER

Interventions

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data collection

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No