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An interim analysis found the study would not be able to reach significance without a large increase in subjects which was not feasible.
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The purpose of the current study is to validate the technology of MRI-based alignment for total knee replacements and to collect data on potential advantages of the computer aided system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer-aided TKA | Experimental | The Visionaire system is a computer-aided system utilizing MRI of the knee prior to TKA surgeries. This technology achieves accurate rotational and A-P position. All of the commonly-referred anatomical landmarks (AP axis, epicondylar axis) are analyzed pre-operatively, allowing for the proper positioning of the implant for each patient. |
|
| Conventional TKA | Other | A conventional TKA utilizes a jig system based on either intra-medullary or extra-medullary guides. No knee MRI is utilized for a conventional TKA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visionaire system (Knee MRI) | Other |
|
| |
| No Knee MRI |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Degrees off normal AP and lateral alignment | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Total blood loss | two days | |
| Operative time | one day | |
| Operative room setup and turnover times |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Burnikel, MD | Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System | Greenville | South Carolina | 29615 | 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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| Other |
|
| one day |
| Procedural cost | one day |