JOURNEY II XR Safety and Effectiveness PMCF
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03136887 |
Recruitment Status :
Active, not recruiting
First Posted : May 2, 2017
Last Update Posted : September 15, 2022
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Condition or disease | Intervention/treatment |
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Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee Unilateral Post-Traumatic Osteoarthritis of Knee Knee Osteoarthritis Degenerative Arthritis Peripheral Joint Failed Osteotomies Failed Unicompartmental Replacement | Device: JOURNEY II XR Total Knee System |
Study Type : | Observational |
Actual Enrollment : | 176 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective, Multicenter, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of the JOURNEY™ II XR Total Knee System |
Actual Study Start Date : | July 28, 2017 |
Estimated Primary Completion Date : | April 2029 |
Estimated Study Completion Date : | April 2029 |

Group/Cohort | Intervention/treatment |
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JOURNEY II XR TKA
This is a single arm study, all subjects will receive JOURNEY II XR TKA
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Device: JOURNEY II XR Total Knee System
JOURNEY II XR Total Knee System |
- Implant survival rate [ Time Frame: 10 years ]Did knee survive with no revision through 10 years
- Knee function [ Time Frame: 10 years ]Lateral Step-Up Test
- Quality of Life - EQ-5D - 3L [ Time Frame: 10 years ]Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire
- Quality of Life - FJS [ Time Frame: 10 years ]Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire
- Quality of Life - KOOS [ Time Frame: 10 years ]Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS) questionnaire
- Quality of Life - ABC scale [ Time Frame: 10 years ]Patient Reported Outcomes using Activities-specific Balance Confidence (ABC) questionnaire
- Quality of Life - SAPSS [ Time Frame: 10 years ]Patient Reported Outcomes using Self-Administered Patient Satisfaction Score (SAPSS) questionnaire
- Physiotherapy (PT) utilization - No. of visits [ Time Frame: 6 Months Post-operatively ]Number of PT visits required up to 6 months after surgery
- Physiotherapy (PT) utilization - Period of visits [ Time Frame: 6 Months Post-operatively ]Time period during which PT appointments are required up to 6 months after surgery
- Radiographic outcomes [ Time Frame: 10 years ]X-rays of index joint
- Adverse Events (AEs) [ Time Frame: 10 years ]All AEs will be collected and reported

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Ages Eligible for Study: | 22 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
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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
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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
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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.).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136887
United States, California | |
Loma Linda University Dept. of Orthopaedic Surgery | |
Loma Linda, California, United States, 92354 | |
United States, Florida | |
Holy Cross Orthopedic Institute | |
Fort Lauderdale, Florida, United States, 33334 | |
United States, Illinois | |
Castle Orthopaedics & Sports Medicine, S.C. | |
Aurora, Illinois, United States, 60504 | |
Midwest Orthopaedics at Rush | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Anne Arundel Medical Center | |
Annapolis, Maryland, United States, 21401 | |
United States, Michigan | |
DeClaire LaMacchia Orthopaedic Institute | |
Rochester, Michigan, United States, 48307 | |
United States, Nevada | |
Reno Orthopaedic Center | |
Reno, Nevada, United States, 89503 | |
United States, New Jersey | |
Mercer Bucks Orthopaedics | |
Hamilton, New Jersey, United States, 08691 | |
United States, New York | |
NYU Hospital for Joint Diseases / NYU Langone Medical Center | |
New York, New York, United States, 10003 | |
Hospital for Special Surgery | |
New York, New York, United States, 10021 | |
Columbia University Center for Hip & Knee Replacement | |
New York, New York, United States, 10032 | |
United States, Ohio | |
The Lindner Research Center at the Christ Hospital | |
Cincinnati, Ohio, United States, 45219 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Washington | |
Providence Regional Medical Center Everett | |
Everett, Washington, United States, 98201 |
Study Chair: | Stacy Leake-Gardner | Smith & Nephew, Inc. |
Responsible Party: | Smith & Nephew, Inc. |
ClinicalTrials.gov Identifier: | NCT03136887 |
Other Study ID Numbers: |
16-4049-06 U1111-1191-7751 ( Other Identifier: WHO ) |
First Posted: | May 2, 2017 Key Record Dates |
Last Update Posted: | September 15, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Arthritis Osteoarthritis Osteoarthritis, Knee Rheumatoid Vasculitis Vasculitis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Arthritis, Rheumatoid Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Vascular Diseases Cardiovascular Diseases Systemic Vasculitis |