JOURNEY II XR Safety and Effectiveness PMCF

Running, not enrolling

Conditions studied: Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee, Unilateral Post-Traumatic Osteoarthritis of Knee, Knee Osteoarthritis, Degenerative Arthritis Peripheral Joint, Failed Osteotomies, Failed Unicompartmental Replacement

In brief

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.

Key facts

Study ID

NCT03136887

Run by

Smith & Nephew, Inc.

People needed

176

Starts

2017-07-28

Expected to finish

2029-04-01

Last updated by the study team

2024-08-12

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement
• have all cruciate and collateral ligaments intact in the index joint
• adult patients that in the judgement of the Investigator are skeletally mature
• be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
• consent to participate in the study by signing the IRB/EC approved informed consent form

You may not qualify if…

• 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
• 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
• 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
• 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.).

Where it is running

• Loma Linda University Dept. of Orthopaedic Surgery — Loma Linda, California, United States
• Holy Cross Orthopedic Institute — Fort Lauderdale, Florida, United States
• Castle Orthopaedics & Sports Medicine, S.C. — Aurora, Illinois, United States
• Midwest Orthopaedics at Rush — Chicago, Illinois, United States
• Anne Arundel Medical Center — Annapolis, Maryland, United States
• DeClaire LaMacchia Orthopaedic Institute — Rochester, Michigan, United States
• Reno Orthopaedic Center — Reno, Nevada, United States
• Mercer Bucks Orthopaedics — Hamilton, New Jersey, United States
• NYU Hospital for Joint Diseases / NYU Langone Medical Center — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia University Center for Hip & Knee Replacement — New York, New York, United States
• The Lindner Research Center at the Christ Hospital — Cincinnati, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Providence Regional Medical Center Everett — Everett, Washington, United States

Full record on ClinicalTrials.gov

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