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It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.
The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities that the patients are familiar with.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ConforMIS iTotal Knee Replacement System | Patients who have had an iTotal knee replacement at least 6 months prior to testing |
| |
| Off-the-Shelf Knee Replacement System | Patients who have had an off-the-shelf knee replacement at least 6 months prior to testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ConforMIS Total Knee Replacement System | Device | Total knee replacement system using a patient specific implant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcome time differences between the two groups | The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants | at least 6 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Outcomes questionnaire- Knee Society Score | Comparing different patient outcome scores between the two groups | At least 6 months post op |
| Outcomes questionnaire- KOOS | Comparing different patient outcome scores between the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include a 1:1 ratio of patients enrolled into both the iTotal arm and the off-the-shelf total knee arm.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Tait, MD | Orthopaedic Institute of Henderson | Principal Investigator |
| Mary O'Connor, MD | Yale University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver-Vail Orthopedics | Parker | Colorado | 80134 | United States | ||
| Institute for Orthopaedic Surgery & Sports Medicine |
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| Off-the-Shelf Knee Replacement System | Device | Total knee replacement system not using a patient specific implant. |
|
| At least 6 months post op |
| Outcomes questionnaire- Forgotten Joint Score | Comparing different patient outcome scores between the two groups | At least 6 months post op |
| Fort Myers |
| Florida |
| 33919 |
| United States |
| Baptist Health South Florida | Miami | Florida | 33176 | United States |
| Coastal Orthopaedic & Sports Medicine Ctr | Port Saint Lucie | Florida | 34996 | United States |
| Bethesda Orthopedic | Bethesda | Maryland | 20817 | United States |
| Excel Orthopaedic Specialists | Woburn | Massachusetts | 01801 | United States |
| Great Lakes Bone & Joint Center | Battle Creek | Michigan | 49015 | United States |
| Lederman-Kwartowitz Center for Orthopedics and Sports Medicine | West Bloomfield | Michigan | 48323 | United States |
| Orthopaedic Institute of Henderson | Henderson | Nevada | 89052 | United States |
| St. Lawrence Health System | Potsdam | New York | 13676 | United States |
| Orthopedic Specialties of Spartanburg | Spartanburg | South Carolina | 29303 | United States |
| Advanced Orthopedics & Sports Medicine | Cypress | Texas | 77429 | United States |
| Vitos Orthopädische Klinik Kassel | Kassel | Germany |
| MedArtes | Neutraubling | Germany |
| Elblandkliniken Stiftung | Radebeul | Germany |
| Sportklinik Stuttgart | Stuttgart | Germany |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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