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The purpose of this study is to evaluate the use and efficacy of the 3DKneeâ„¢ System for total knee replacement surgery.
Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKneeâ„¢ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKneeâ„¢ System and who are candidates for primary knee arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3DKnee | Post Market Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3DKneeâ„¢ System | Device | Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of total knee system | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| change in Knee Society Score | 5 year | |
| change in pain from pre-op to post-op | 5 year | |
| patient satisfaction |
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Inclusion Criteria:
This must be a primary knee replacement on this knee.
Patient is over 18 years of age or older
Have knee joint disease related to one or more of the following
Patient is likely to be available for evaluation for the duration of the study
Able and willing to sign the informed consent and follow study procedures
Patient is not pregnant
Exclusion Criteria:
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Patients who are over 18 years of age and are candidates for a primary total knee replacement.
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| Name | Affiliation | Role |
|---|---|---|
| John W. McAllister, M.D. | St. Peter's Bone and Joint Surgery | Principal Investigator |
| Barry J Waldman, M.D. | OrthoMaryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longo Orthopedics | Scottsdale | Arizona | 85251 | United States | ||
| Center for Excellence |
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| Label | URL |
|---|---|
| Sponsor company home page | View source |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| 5 year |
| change in WOMAC Osteoarthritis Index from pre-surgery | 5 year |
| change in Oxford Knee Score from pre-surgery | 5 year |
| Fresno |
| California |
| 93710 |
| United States |
| OrthoMaryland | Baltimore | Maryland | 21209 | United States |
| Metro Orthopedics and Sports Therapy | Silver Spring | Maryland | 20910 | United States |
| Leslie Orthopedics and Sports Medicine | Camdenton | Missouri | 65020 | United States |
| St. Peter's Bone & Joint Surgery | City of Saint Peters | Missouri | 63376 | United States |
| Texas Center for Joint Replacement | Plano | Texas | 75093 | United States |
| Rimrock Orthopedics | St. George | Utah | 84790 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |