Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
170 participants
OBSERVATIONAL
2015-09-30
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Device:JOURNEY™ II CR Total Knee System (J II CR TKS)
Subjects having TKA with JOURNEY™ II CR Total Knee System
JOURNEY™ II CR Total Knee System (J II CR TKS)
TKA with Journey II CR Total Knee System
Interventions
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JOURNEY™ II CR Total Knee System (J II CR TKS)
TKA with Journey II CR Total Knee System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
22 Years
75 Years
ALL
Yes
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lucy O'Mara
Role: STUDY_CHAIR
Smith & Nephew, Inc.
Locations
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Orthopedic Institute of the West
Phoenix, Arizona, United States
Rush University Medical Center
Chicago, Illinois, United States
Anne Arundel Health System Research Institute, Inc
Annapolis, Maryland, United States
Center for Hip and Knee Replacement at Columbia University Medical Center
New York, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network
Cincinnati, Ohio, United States
Hospital Parc Taulí Servei de Cirurgia Ortopèdica I Traumatologia
Barcelona, , Spain
Royal National Orthopaedic Hospital NHS Trust
Stanmore, , United Kingdom
Barts Health NHS Trust
Whitechapel, , United Kingdom
Countries
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Other Identifiers
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13-4049-06
Identifier Type: -
Identifier Source: org_study_id