New knee implant aims to improve mobility for arthritis patients
NCT ID NCT02440672
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well a new knee replacement system, the JOURNEY™ II CR, works for people with knee osteoarthritis. About 170 adults aged 22 to 75 who need a total knee replacement will receive the implant. Researchers will measure knee movement, survival of the implant, and quality of life over up to 10 years.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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170 people
The number who actually took part.
- Start date
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Sep 2015
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Subjects who present with DJD of the knee will be screened to determine if they meet all inclusion and no exclusion criteria. If all entry criteria are achieved, the subject will be eligible to participate in the study. All general and indication-specific entry criteria must be met prior to study entry.
- Ages
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22 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Subjects MUST meet ALL of the following criteria for inclusion in the study: 1. Has signed the IRB/EC approved ICF specific to this study prior to study participation 2. Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee 3. Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by one of the following: * Post-traumatic arthritis * Osteoarthritis * Degenerative arthritis 4. Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral) 5. Is in general good health (as determined by the Investigator) based on screening assessments and medical history 6. Is independent, ambulatory, and can comply with all post-operative evaluations 7. plans to be available through ten (10) years post-operative follow-up Exclusion Criteria: 1\. Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria: * Any of the following conditions in the index joint: * does not require patella resurfacing * has received a TKA or unicondylar arthroplasty * has inadequate bone stock to support the device (e.g. severe osteopenia/osteoporosis) * Any of the following conditions in the contralateral joint: * has enrolled in the study for the contralateral knee * has received TKA as a revision for a failed total or unicondylar knee arthroplasty * has received a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning, as determined by Investigator * Any of the following conditions of the hip: * received contralateral or ipsilateral revision hip arthroplasty * has ipsilateral hip arthritis resulting in flexion contracture * has received a ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty, that is not fully healed and well-functioning, as determined by Investigator * Has diagnosis of an immunosuppressive disorder * Has presence of malignant tumor, metastatic, or neoplastic disease * Has family history of severe osteoporosis/osteopenia * Has a known allergy to study device or one or more of its components * Has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) * Is receiving medication for the diagnosis of fibromyalgia * has a lower extremity condition causing abnormal or restricted ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture) * Is pregnant or plans to become pregnant during the study * Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study and complete PROs, as determined by Investigator * Has a BMI \> 40 * Is currently enrolled in or has participated in another investigational drug, biologic, or device study within 3 months of enrollment * Is currently involved in personal injury litigation or a worker's compensation claim * Is facing current or impending incarceration * Is known to be at risk for lost to follow-up, or failure to return for scheduled visits
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Anne Arundel Health System Research Institute, Inc
Annapolis, Maryland, 21401, United States
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Barts Health NHS Trust
Whitechapel, United Kingdom
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Center for Hip and Knee Replacement at Columbia University Medical Center
New York, New York, 10032, United States
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Hospital Parc Taulí Servei de Cirurgia Ortopèdica I Traumatologia
Barcelona, Spain
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Orthopedic Institute of the West
Phoenix, Arizona, 85054, United States
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Royal National Orthopaedic Hospital NHS Trust
Stanmore, United Kingdom
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network
Cincinnati, Ohio, 45219, United States
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Wake Forest University
Winston-Salem, North Carolina, 27157, United States
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Other studies related to the condition(s) this trial covers.
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