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| Name | Class |
|---|---|
| Medacta USA | INDUSTRY |
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The study is a prospective, randomized comparison of total knee arthroplasty with the Medacta GMK Sphere® knee compared to the Medacta GMK PS knee, with comparison to data from previous trials of similar study design.
There is no consensus within the Arthroplasty community as to whether a traditional post and cam-style PS 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 TKA implants. Almost all such studies have been retrospective, and/or non-randomized, and/or utilizing older generation devices.
The primary objective of this study is to compare the average Forgotten Knee Score (FJS) of those patients receiving the Medacta GMK Sphere knee with the average FJS of those receiving the Medacta GMK PS knee at the two and five year time points. It is expected that those subjects implanted with the Medacta GMK Sphere knee will show significantly better Forgotten Joint Scores at two and five year follow-up when compared with those receiving the Medacta GMK PS knee. The FJS was not collected in the prior comparison studies, and so cannot be evaluated across the knee systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medacta GMK Sphere® Medial-Pivot Knee Prosthesis | Other | Research subjects in this arm received GMK Sphere. |
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| Medacta GMK PS Posterior Stabilized Knee Prosthesis | Other | Research subjects in this arm received GMK PS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medacta GMK Sphere® Medial-Pivot Knee Prosthesis | Device |
| ||
| Medacta GMK PS Posterior Stabilized Knee Prosthesis |
| Measure | Description | Time Frame |
|---|---|---|
| Forgotten Joint Score (FJS) | The average Forgotten Joint Score (FJS) of those patients receiving the Medacta GMK Sphere® knee prosthesis will be compared with the average FJS of those receiving the Medacta GMK PS knee prosthesis. The FJS total score range is 0-100, with higher scores indicating a higher degree of "forgetting" the artificial joint, that is, a lower degree of awareness. | Change from baseline at 2 years and 5 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Total Knee Society Score (KSS) | Clinical outcomes will be evaluated via the Knee Society Score (KSS). The KSS is subdivided into a Knee Assessment score which rates only the knee joint itself, and a Functional Assessment score which rates the subject's ability to walk and climb stairs. Both scores range from 0-100, with a higher score indicating a better outcome. | Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Scott, MD | Spokane Joint Replacement Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spokane Joint Replacement Center | Spokane | Washington | 99218 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Device |
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| Lower Extremity Activity Scale (LEAS) | Clinical outcomes will be evaluated via the Lower Extremity Activity Scale (LEAS). The LEAS scale range is 1-18, with a higher value indicating a higher level of activity. | Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative |
| Radiographic Analysis | Radiographs will be assessed for radiolucency, migration and subsidence. An AP Longstanding view will be obtained pre-operatively, and at 6 weeks and 1 year post-operatively to determine degree of Varus or Valgus. | Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative |