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This is a retrospective/prospective, open-label single cohort, multicenter study to collect relevant clinical data from 147 subjects with unicompartmental degeneration of the knee in whom the Journey UNI UKS was previously implanted.
The purpose of the current investigation is to assess the safety and effectiveness of the JOURNEY UNI Unicompartmental Knee System (UKS) in patients with non-inflammatory degenerative joint disease (NIDJD) of the knee who previously had the Journey UNI UKS implanted. This clinical study will prospectively evaluate the 36 and 60-month safety and performance of the JOURNEY UNI UKS in patients with NIDJD of the knee who required lateral or medial knee compartment replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Journeyâ„¢ UNI Unicompartmental Knee System | Subjects previously received knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Journey UNI Unicompartmental Knee System | Device | Lateral or medial knee compartment replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival rate | Did knee survive with no revision through 5 years | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life - KSS | 2011 Knee Society Score | 5 Years |
| Quality of Life - EQ-5D - 3L | EuroQol Five Dimensions Questionnaire | 5 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Investigators will pre-screen all subjects that have previously undergone UKA using the Journey UNI UKS system between 12 and 48 months previously using only the existing information in the medical records.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Specialists of Central Arizona-Scottsdale | Scottsdale | Arizona | 85255 | United States | ||
| Orthopaedic Surgery Specialists, Ltd. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Quality of Life - SAPSS | Self-Administered Patient Satisfaction Survey | 5 Years |
| Quality of Life - Forgotten Joint Score | Forgotten Joint Score (FJS) questionnaire measures how often subject is aware of affected knee in everyday life. Score consists of 12 questions where subjects are asked to rate their awareness of their joint replacement during various activities. rating is never, almost never, seldom, sometimes or mostly. | 5 Years |
| Adverse Events (AEs) | All AEs will be collected and reported | 5 Years |
| Radiographic Outcomes | Perform weight-bearing AP and lateral standard x-rays | 5 Years |
| Park Ridge |
| Illinois |
| 60068 |
| United States |
| Tennesee Orthopaedic Alliance, P.A. | Nashville | Tennessee | 37209 | United States |
| London Health Sciences Centre-University Hospital | London | Ontario | N6A5A5 | Canada |
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |