A Prospective, Non-randomized, Consecutive Series, Multicenter, Post-Market Study to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System

Completed

• Conditions: 10023213; 10005944; cartilage damage; Osteoarthritis

• Registration Number: NL-OMON55575
• Lead Sponsor: Smith & Nephew Orthopaedics AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

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 (>18y), agrees to consent to and to follow
the study visit schedule (as defined in the study protocol and informed consent
form), by signing the EC approved informed consent form

Exclusion Criteria

- age > 75 years
- subjects with immunosuppressive disorders
- subject has severe pronation of the ipsilateral foot or any other relevant
clinical condition contributing to abnormal ambulation (including but not
limited to ankle fusion, ankle arthroplasty, previous hip fracture, ipsilateral
hip arthritis resulting in flexion contracture)
- patient has undergone a previous major surgery to the study knee (including
but not limited to osteotomy, fracture fix, medial or lateral ligament surgery)
- subject has active infection or sepsis (treated or untreated)
- At the time of enrollment, subject has one or more arthroplasties that are
not fully healed and well-functioning, as determined by the investigator
- subject has presence of malignant tumor, metastatic, or neoplastic disease
- subject has conditions that may interfere with the TKA survival or outcome
- subject has inadequate bone stock to support the device (severe osteopenia,
family history of severe osteoporosis or osteopenia)
- subject has an emotional or neurological condition that would pre-empt their
ability or willingness to participate in the study
- subject has a BMI>40

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Revision for any reason (*revision* will be defined as the exchange of one or<br /><br>more components)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- EQ-5D<br /><br>- 2011 KSS<br /><br>- Adverse events<br /><br>- Radiographic evaluation</p><br>