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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1191-7751 | Other Identifier | WHO |
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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.
Total knee arthroplasty (TKA) is considered the most beneficial and cost-effective treatment for end-stage knee arthritis and is the most frequently performed joint replacement surgery. TKA is also indicated for earlier osteoarthritis (OA) interventions, such as osteotomy or unicompartmental replacement, when additional treatment is warranted. One device option available once the decision is made to perform TKA is the JOURNEY II XR Total Knee System. The JOURNEY II XR Total Knee System is designed to be a more "natural feeling" total knee replacement. The goal of the JOURNEY II XR is to enable a higher level of function after total knee replacement by relieving pain and restoring the ability to participate in active lifestyles. The main aim of this study is to generate long-term safety and performance data for the JOURNEYâ„¢ II XR Total Knee System. Effectiveness information such as short- and long-term function, subject satisfaction, and quality of life will also be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JOURNEY II XR TKA | This is a single arm study, all subjects will receive JOURNEY II XR TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JOURNEY II XR Total Knee System | Device | JOURNEY II XR Total Knee System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival rate | Did knee survive with no revision through 10 years | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Knee function | Lateral Step-Up Test | 10 years |
| Quality of Life - EQ-5D - 3L | Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
have any of the following conditions in the index joint:
have any of the following conditions in the contralateral joint:
have any of the following conditions of the hip:
have a diagnosis of an immunosuppressive disorder
have an active infection, treated or untreated, systemic or at the site of the planned surgery
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
have a BMI > 40
be facing current or impending incarceration
have a known allergy to study device or one or more of its components
be pregnant or have plans to become pregnant during the course of the study
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
be enrolled in another drug, biologic, or device study within 30 days of screening
be known to be at risk for lost to follow-up or failure to return for scheduled visits
during the surgery, have a cruciate ligament tibial bone island that is secured with any fixative device (e.g. screw, plate, etc.).
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Patients will be selected from their orthopedic surgeons practice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Dept. of Orthopaedic Surgery | Loma Linda | California | 92354 | United States | ||
| Holy Cross Orthopedic Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24249702 | Background | Singh JA, Lewallen DG. Time trends in the characteristics of patients undergoing primary total knee arthroplasty. Arthritis Care Res (Hoboken). 2014 Jun;66(6):897-906. doi: 10.1002/acr.22233. | |
| 22398175 | Background | Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6. |
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| 10 years |
| Quality of Life - FJS | Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire | 10 years |
| Quality of Life - KOOS | Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS) questionnaire | 10 years |
| Quality of Life - ABC scale | Patient Reported Outcomes using Activities-specific Balance Confidence (ABC) questionnaire | 10 years |
| Quality of Life - SAPSS | Patient Reported Outcomes using Self-Administered Patient Satisfaction Score (SAPSS) questionnaire | 10 years |
| Physiotherapy (PT) utilization - No. of visits | Number of PT visits required up to 6 months after surgery | 6 Months Post-operatively |
| Physiotherapy (PT) utilization - Period of visits | Time period during which PT appointments are required up to 6 months after surgery | 6 Months Post-operatively |
| Radiographic outcomes | X-rays of index joint | 10 years |
| Adverse Events (AEs) | All AEs will be collected and reported | 10 years |
| Fort Lauderdale |
| Florida |
| 33334 |
| United States |
| Castle Orthopaedics & Sports Medicine, S.C. | Aurora | Illinois | 60504 | United States |
| Midwest Orthopaedics at Rush | Chicago | Illinois | 60612 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| DeClaire LaMacchia Orthopaedic Institute | Rochester | Michigan | 48307 | United States |
| Reno Orthopaedic Center | Reno | Nevada | 89503 | United States |
| Mercer Bucks Orthopaedics | Hamilton | New Jersey | 08691 | United States |
| NYU Hospital for Joint Diseases / NYU Langone Medical Center | New York | New York | 10003 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Columbia University Center for Hip & Knee Replacement | New York | New York | 10032 | United States |
| The Lindner Research Center at the Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | United States |
| 17719803 | Background | Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27. |
| 11014340 | Background | Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available. |
| 14644851 | Background | Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742. |
| 15173310 | Background | NIH Consensus Panel. NIH Consensus Statement on total knee replacement December 8-10, 2003. J Bone Joint Surg Am. 2004 Jun;86(6):1328-35. doi: 10.2106/00004623-200406000-00031. No abstract available. |
| 24792950 | Background | Dowsey MM, Gunn J, Choong PF. Selecting those to refer for joint replacement: who will likely benefit and who will not? Best Pract Res Clin Rheumatol. 2014 Feb;28(1):157-71. doi: 10.1016/j.berh.2014.01.005. |
| 15550426 | Background | Gidwani S, Fairbank A. The orthopaedic approach to managing osteoarthritis of the knee. BMJ. 2004 Nov 20;329(7476):1220-4. doi: 10.1136/bmj.329.7476.1220. No abstract available. |
| 14996871 | Background | Parvizi J, Hanssen AD, Spangehl MJ. Total knee arthroplasty following proximal tibial osteotomy: risk factors for failure. J Bone Joint Surg Am. 2004 Mar;86(3):474-9. doi: 10.2106/00004623-200403000-00003. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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