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| Name | Class |
|---|---|
| Ochsner Health System | OTHER |
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The purpose of this study is to obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty.
This study aims to use up to 75 patients at 3 centers to determine a baseline short-term post-operative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total knee arthroplasty patients | ConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty patients | Device | ConforMIS iTotal (CR) knee implant system & off-the-shelf standard knee implant system from various manufacturers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Timed Functional Tests at 6 weeks | Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests. | 6 weeks post-op |
| Timed Functional testing at 6 months | Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests. | 6 months post op |
| Timed Functional Testing at 1 year | Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests. | 1 year post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome questionnaires at 6 weeks | Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients. | 6 weeks post-op |
| Outcome questionnaires at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Total knee arthroplasty patients
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| Name | Affiliation | Role |
|---|---|---|
| Deryk Jones, MD | Ochsner Heath System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
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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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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| D019643 | Arthroplasty, Replacement |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.
| 6 months post-op |
| Outcome questionnaires at 1 year | Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients. | 1 year post op |
| D019919 | Prosthesis Implantation |