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NCT02921594 was not a RCT but a secondary pilot study designed to establish a fluoroscopic test-set up on 10 selected patients from another RCT.
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Primary: The primary objective of this pilot study is to compare the intraarticular kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.
Secondary: The secondary objective of this pilot study is to compare the standing balance by force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total knee arthroplasty with Vanguard XP | Active Comparator | The new Vanguard XP Total knee arthroplasty system is a further development of the Vanguard TKA. The new Vanguard XP system both cruciate ligaments are preserved. |
|
| Total knee arthroplasty with Vanguard CR | Active Comparator | Total knee arthroplasty system without preservation of the anterior cruciate ligament |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty with Vanguard XP | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Anterior-posterior translation of the femoral component with respect to the tibia component | Group mean in millimeters (mm) | at least one year post surgery |
| Axial rotation of the femoral component with respect to the tibia component | Group mean in degrees (°) | at least one year post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Traveled distance of center of pressure | Group mean in centimeters (cm) | at least one year post surgery |
| Velocity of center of pressure | Group mean in mm/second |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre | Hvidovre | 2650 | Denmark |
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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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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Total knee arthroplasty with Vanguard CR |
| Device |
|
| at least one year post surgery |
| Rambling-trembling distance | Group mean in mm | at least one year post surgery |
| Isometric quadriceps muscle strength | Group mean in newton meter pr. kilograms weight (Nm/kg) | at least one year post surgery |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |