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This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.
Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available. . All data will be collected from existing medical records and from single follow up call/email.
Demographics and Medical History
Pre & Post-Operative Data including Range of Motion
Surgical Data
Survivorship (phone/email or last known visit)
Patient Reported Outcomes (phone/email single time point visit)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ConforMIS PS Group | Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTotal Posterior Stabilized (PS) Knee Replacement System | Device | Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demographics and Medical History | Demographics and medical history gathered from medical records | 1 year |
| Pre and Post Operative Range of Motion | Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
1. BMI > 40
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Individuals who are 18 years or older and have received a ConforMIS iTotal PS knee replacement to treat any condition indicated on the device's instructions for use.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Orthopaedic Alliance | Nashville | Tennessee | 37203 | United States | ||
| Scott Orthopedic Center |
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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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| Huntington |
| West Virginia |
| 25702 |
| United States |