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The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.
This is a prospective, non-randomized, single cohort, multicenter study to evaluate the clinical outcomes of TKA using the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement. One hundred and seventy (170) subjects will be enrolled at up to 18 clinical sites globally. Follow-up clinical assessments will be performed at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device:JOURNEY™ II CR Total Knee System (J II CR TKS) | Subjects having TKA with JOURNEY™ II CR Total Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JOURNEY™ II CR Total Knee System (J II CR TKS) | Device | TKA with Journey II CR Total Knee System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM | 1 year post-op analysis | |
| Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively | Up to 10 year post-operative analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes: EuroQol 5D (EQ-5D) scale | Pre-Op to 10 yrs | |
| Clinical Outcomes: 2011 Knee Society Score (2011 KSS) clinical evaluation | Pre-Op to 10 yrs | |
| Clinical Outcomes: Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty (SAPSS |
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Inclusion Criteria:
Subjects MUST meet ALL of the following criteria for inclusion in the study:
Has signed the IRB/EC approved ICF specific to this study prior to study participation
Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee
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:
Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral)
Is in general good health (as determined by the Investigator) based on screening assessments and medical history
Is independent, ambulatory, and can comply with all post-operative evaluations
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:
Any of the following conditions in the contralateral joint:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Keji Alao | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Institute of the West | Phoenix | Arizona | 85054 | United States | ||
| Rush University Medical Center |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Pre-Op to 10 yrs |
| Health Economic Endpoints : Physical therapy visit quantification/duration | 30, 60, and 90-day hospital re-admission rate |
| Health Economic Endpoints: Discharge destination(s)/length of stay | 30, 60, and 90 days |
| Health Economic Endpoints: Unscheduled professional visits (e.g. hospital, emergency room, orthopedic clinic, primary care physician) | 30, 60, and 90 days |
| Health Economic Endpoints: Concomitant medications/procedures associated with the knee | 30, 60, and 90 days |
| Safety Endpoints:Adverse events, to be evaluated by type, frequency, severity, and relatedness to the study treatment. | Pre-Op to 10 yrs |
| Safety Endpoints: Manipulations under anesthesia | Pre-Op to 10 yrs |
| Safety Endpoints: Radiographic analysis | Pre-Op to 10 yrs |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Anne Arundel Health System Research Institute, Inc | Annapolis | Maryland | 21401 | United States |
| Center for Hip and Knee Replacement at Columbia University Medical Center | New York | New York | 10032 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network | Cincinnati | Ohio | 45219 | 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 |