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This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTotal KRS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTotal KRS | Device | Total Knee Replacement System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Function | Range of Motion | Average of 7 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Revision Rate | Number of knees that required a reoperation to remove/replace/add implant components | Average of 7 months |
| Number of Transfusions | Number of knees that required a blood transfusion during the initial hospital stay post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have received an iTotal Knee replacement
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| STAR Orthopedics | La Quinta | California | 92253 | United States | ||
| Preferred Orthopedics of the Palm Beaches |
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| ID | Title | Description |
|---|---|---|
| FG000 | iTotal KRS | iTotal KRS: Total Knee Replacement System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
106 knees (bilateral)
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| ID | Title | Description |
|---|---|---|
| BG000 | iTotal KRS | iTotal KRS: Total Knee Replacement System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knee Function | Range of Motion | Posted | Mean | Full Range | degrees | Average of 7 months post-operative | Knees | Knees |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iTotal KRS | iTotal KRS: Total Knee Replacement System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Manipulations | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Quartulli, VP Clinical Affairs | ConforMIS | 781-345-9191 | marc.quartulli@conformis.com |
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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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| Initial hospital stay |
| Manipulations Under Anesthesia | Number of knees that required a subsequent procedure to restore knee range of motion | Up to 7 months post-operative |
| Boynton Beach |
| Florida |
| 33437 |
| United States |
| Tennessee Orthopaedic Alliance | Nashville | Tennessee | 37203 | United States |
| Central Utah Clinic | Provo | Utah | 84604 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Knees |
|
|
| Secondary | Revision Rate | Number of knees that required a reoperation to remove/replace/add implant components | bilaterals were included | Posted | Count of Units | Knees | Average of 7 months | Knees | Knees |
|
|
|
| Secondary | Number of Transfusions | Number of knees that required a blood transfusion during the initial hospital stay post-operative | Posted | Number | number of knees requiring transfusion | Initial hospital stay | Knees | Knees |
|
|
|
| Secondary | Manipulations Under Anesthesia | Number of knees that required a subsequent procedure to restore knee range of motion | Posted | Count of Units | Knees | Up to 7 months post-operative | Knees | Knees |
|
|
|
| 5 |
| 89 |
| 0 |
| 89 |
| Revision/Poly Swap | Surgical and medical procedures | Thicker insert implanted at 11 months post-op |
|
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