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Clinical Trials in the USA / NCT03136887
Active, not recruiting Observational

JOURNEY II XR Safety and Effectiveness PMCF

NCT03136887 · tracked via the Priya Life Science USA tracker
Sponsor
Smith & Nephew, Inc.
Phase
Observational
Started
2017-07-28
Last updated
2024-08-12

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

Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
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)

Trial sites (14)

FacilityCityRegionStatus
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

More Smith & Nephew, Inc. trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03136887 on ClinicalTrials.gov ↗ ← All trials in the USA