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This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta GMK Sphere® knee at the two and five year time points. 70 subjects, enrolled at the data coordinating center in Medacta GMK Sphere® vs Posterior Stabilized study (WIRB Pro Num: 20141994) and randomized to the Sphere arm, will have their data utilized for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medacta GMK Sphere® Knee Prosthesis | Other | All subjects enrolled will receive the Medacta GMK Sphere® Medial Knee Prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medacta GMK Sphere® Medial Knee Prosthesis | Device | There is no consensus within the Arthroplasty community as to whether a traditional post and cam-style Posterior Stabilized total knee device is superior to a medial-pivot, more congruent device. However, the majority of surgeons seem to prefer the former, though there is a minority that uses the latter device with great success. To date, there have been few prospective trials directly comparing these devices, and none with the latest generation of Total Knee Arthroplasty implants. Almost all such studies have been retrospective and/or utilizing older generation devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the change in Forgotten Knee Scores (FJS) of those patients receiving the Medacta GMK Sphere from baseline to years 2 and 5 post-operatively. | Knee function-patients ability to forget the artificial joint in everyday life. | Baseline, 2 and 5 year time points |
| Measure | Description | Time Frame |
|---|---|---|
| Total Knee Society Score (KSS) | Total Knee Society score questionnaire to assess pain and function | Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years. |
| Krackow Activity Scale (KAS) | The Krackow Activity Scale (KAS) lower extremity activity scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norhtwestern University | Chicago | Illinois | 60611 | United States | ||
| Tulane University |
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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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|
|
| Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years |
| Radiographic Analysis | Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years |
| AP long standing X-ray | Determine degree of Varus or Valgus | Pre-operative and 6 weeks |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| McBride Orthopedic Hospital | Oklahoma City | Oklahoma | 73103 | United States |
| Texas Orthopedics | Austin | Texas | 78759 | United States |
| Spokane Joint Replacement Center | Spokane | Washington | 99218 | United States |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |