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The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic side, which is currently the traditional method.
The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant receives bilateral knee CT preoperatively | Experimental | The P.I. (Dr. Malkani) will use normal contralateral side joint numbers as the target alignment for RA-TKA |
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| Participant receives unilateral CT of the operative knee preoperatively | Active Comparator | The P.I. will use the traditional method to obtain target alignment for RA-TKA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT scan unilateral knee | Diagnostic Test | Intervention given to the Active Comparator arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Satisfaction | Overall Satisfaction with TKA using a Likert scale | 1-year postoperatively |
| Pain VAS | Level of knee pain (scale of zero to ten) using the Visual Analog Scale (VAS) | preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively |
| KOOS JR | KOOS JR questionnaire | preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively |
| Forgotten Joint Score | FJS-12 questionnaire | preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively |
| PROMIS-10 Mental and Physical Health scores | PROMIS-10 Global Health questionnaire | preoperatively and 1-year postoperatively |
| Incidence of revision TKA | postoperative complication requiring a revision total knee arthroplasty | 1 year postop |
| non-revision complication | postoperative complication requiring a non-revision procedure | 1 year postop |
| Measure | Description | Time Frame |
|---|---|---|
| Active ROM | Active knee range of motion: active extension, active flexion | preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UofL Health | Louisville | Kentucky | 40202 | United States |
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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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Prospective, randomized cohort analysis study
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| CT scan bilateral knee | Diagnostic Test | Intervention given to the Experimental Arm |
|