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Decision of investigational team
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To evaluate the ConforMIS iDuo G2 implant
This is a prospective, multicenter study. The investigators will be evaluating the ConforMIS iDuo G2 implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iDuo G2 | iDuo G2 to be implanted in the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iDuo G2 | Device | single comparator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain and function | By using questionnaires, we will look at pain and function scores at this time point | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and function at follow up time points | By using questionnaires, we will look at pain and function scores at these time points | 1, 2, 5 and 10 years post implant |
| Revision rates | Capture revision rates |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting this specific form of osteoarthritis at participating sites with IRB approval.
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| Name | Affiliation | Role |
|---|---|---|
| L Rolston, MD | Forest Ridge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Ridge Medical Pavilion | New Castle | Indiana | 47362 | United States | ||
| Ochsner Sports Medicine Institute |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Patient will be observed for 10 years post implant |
| Incidence of major procedure related and device related complications | To capture any procedure or device related complications | Patient will be observed for 10 years post implant |
| Post operative limb alignment | X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups |
| Radiographic implant position | X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups |
| Radiographic loosening, radiolucencies | X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups |
| Length of procedure | Timing from skin to cement | Day of surgery |
| Length of hospital stay | measure length of stay from admission to discharge | Patient will be followed from admission to discharge with an average of about 5 days |
| Blood loss during surgery | Day of surgery |
| Intraoperative blood replacement volume | Day of surgery |
| New Orleans |
| Louisiana |
| 70121 |
| United States |
| Mansfield Orthopaedics | Morrisville | Vermont | 05661 | United States |