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Logistics of study did not allow for consistent data collection
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The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEYâ„¢ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings to patients, the facility and/or the payer.
To address the study objectives, patient self-assessment questionnaires, and other objective measures of post-operative function and health care resource utilization will be used for data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Journey II BCS Knee | Physical Therapy Observational | ||
| All Other Posterior Stabilized Knees | Physical Therapy Observational |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups | The absolute Range of Motion of index knee will be compared between groups | ≤7 days of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis and who will receive either the Journey II BCS knee or any other posterior stabilized knee.
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| Name | Affiliation | Role |
|---|---|---|
| Beate Hanson, MD | Smith & Nephew, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anne Arundel Medical Cneter | Annapolis | Maryland | 21401 | United States | ||
| Slocum Research & Educational Foundation |
Study terminated therefore no data sharing planned
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Eugene |
| Oregon |
| 97401 |
| United States |
| University Orthopaedic Center | State College | Pennsylvania | 16801 | United States |