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Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Pre-operative and operative assessments collected retrospectively. All postoperative assessments beginning at the 6 month post-operative time point collected prospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Journey II BCS TKA | Subjects who previously received TKA with Journey II BCS Total Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKA with Journey II BCS Total Knee System | Device | TKA with Journey II BCS Total Knee System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ITB Friction Pain | 6 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively | |
| Radiographic Evaluation | Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
Subject received the JOURNEYâ„¢ II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
Subject possesses a contralateral or ipsilateral revision hip arthroplasty
Subject has ipsilateral hip arthritis resulting in flexion contracture
At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:
At the time of surgery, subject had an active infection or sepsis (treated or untreated)
At the time of surgery, subject had presence of malignant tumor, metastatic, or neoplastic disease
At the time of surgery, subject had 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)
At the time of surgery, subject had contralateral lower extremity condition causing abnormal ambulation
Subject is pregnant or plans to become pregnant during the study
Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
At the time of surgery, subject had a BMI>40
At the time of enrollment, subject has a BMI>40
Subject is enrolled in another investigational drug, biologic, or device study
Subject is facing current or impending incarceration
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Subjects receiving the JOURNEYâ„¢ II BCS Total Knee System
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Replacement Institute at St. Vincent Medical Center | Los Angeles | California | 90057 | United States | ||
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| Knee Society Score | 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively |
| Fort Wayne Orthopedics |
| Fort Wayne |
| Indiana |
| 46804 |
| United States |
| Methodist Sports Medicine/The Orthopedic Specialist | Indianapolis | Indiana | 46280 | United States |
| Hospital for Special Surgery | New York | New York | 10021-4892 | United States |
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157-1070 | United States |
| Wellington Orthopaedics | Cincinnati | Ohio | 45220 | United States |
| Cincinnati Orthopaedic Research Institute | Cincinnati | Ohio | 45249 | United States |
| Minimally Invasive Orthopaedics | Columbus | Ohio | 43215 | United States |
| Tennessee Orthopaedic Clinics | Knoxville | Tennessee | 37923 | United States |
| San Antonio Orthopaedic Specialists | San Antonio | Texas | 78229 | United States |
| Evergreen Orthopaedic Clinic | Kirkland | Washington | 98034 | United States |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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