Active, not recruiting
Observational
JOURNEY II XR Safety and Effectiveness PMCF
Condition(s) studied
Rheumatoid Vasculitis With Rheumatoid Arthritis of KneeUnilateral Post-Traumatic Osteoarthritis of KneeKnee OsteoarthritisDegenerative Arthritis Peripheral JointFailed OsteotomiesFailed Unicompartmental Replacement
Investigational drug(s) / intervention(s)
JOURNEY II XR Total Knee System
JOURNEY II XR Total Knee System: JOURNEY II XR Total Knee System
Study summary
This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.
Eligibility
Inclusion Criteria:
1. require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement
2. have all cruciate and collateral ligaments intact in the index joint
3. adult patients that in the judgement of the Investigator are skeletally mature
4. be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
5. consent to participate in the study by signing the IRB/EC approved informed consent form
Exclusion Criteria:
1. have any of the following conditions in the index joint:
* Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
* Significant varus or valgus deformities (\>15º)
* Incomplete or insufficient tissue surrounding the knee
* Collateral ligament insufficiency
* Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems
* History of prior TKA
2. have any of the following conditions in the contralateral joint:
* a previous TKA as a revision for a failed total or unicondylar knee arthroplasty
* a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning as determined by the Investigator
3. have any of the following conditions of the hip:
* a previous contralateral or ipsilateral revision hip arthroplasty
* ipsilateral hip arthritis resulting in flexion contracture
* previously received an ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well-functioning as determined by the Investigator
4. have a diagnosis of an immunosuppressive disorder
5. have an active infection, treated or untreated, systemic or at the site of the planned surgery
6. have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease
7. have a BMI \> 40
8. be facing current or impending incarceration
9. have a known allergy to study device or one or more of its components
10. be pregnant or have plans to become pregnant during the course of the study
11. have, in the opinion of the Investigator, an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
12. be enrolled in another drug, biologic, or device study within 30 days of screening
13. be known to be at risk for lost to follow-up or failure to return for scheduled visits
14. during the surgery, have a cruciate ligament tibial bone island that is secured with any fixative device (e.g. screw, plate, etc.).
Primary outcome measure(s)
- Implant survival rate — 10 years
Did knee survive with no revision through 10 years
Trial sites (14)
| Facility | City | Region | Status |
| Loma Linda University Dept. of Orthopaedic Surgery |
Loma Linda |
California |
|
| Holy Cross Orthopedic Institute |
Fort Lauderdale |
Florida |
|
| Castle Orthopaedics & Sports Medicine, S.C. |
Aurora |
Illinois |
|
| Midwest Orthopaedics at Rush |
Chicago |
Illinois |
|
| Anne Arundel Medical Center |
Annapolis |
Maryland |
|
| DeClaire LaMacchia Orthopaedic Institute |
Rochester |
Michigan |
|
| Reno Orthopaedic Center |
Reno |
Nevada |
|
| Mercer Bucks Orthopaedics |
Hamilton |
New Jersey |
|
| NYU Hospital for Joint Diseases / NYU Langone Medical Center |
New York |
New York |
|
| Hospital for Special Surgery |
New York |
New York |
|
| Columbia University Center for Hip & Knee Replacement |
New York |
New York |
|
| The Lindner Research Center at the Christ Hospital |
Cincinnati |
Ohio |
|
| Oregon Health & Science University |
Portland |
Oregon |
|
| Providence Regional Medical Center Everett |
Everett |
Washington |
|
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