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The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Target vs. Actual Correction | Measured as either weight-bearing line (percent) or HKA angle (degrees) | Participants will be followed for the duration of correcting their deformity, an average of 3 weeks |
| Target vs. Actual Correction | Measured as either weight-bearing line (percent) or HKA angle (degrees) | Participants will be followed for the duration of consolidation (bone healing), an average of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight-Bearing Line | Measured in percent | Participants will be followed for the duration of correcting their deformity, an average of 3 weeks |
| Change in Weight-Bearing Line | Measured in percent |
| Measure | Description | Time Frame |
|---|---|---|
| All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) | Participants will be followed through 2 years post-operative | |
| All non-serious adverse events in the limb related to the device or study procedure. Study procedure includes implant procedure and correction lengthening procedure. |
Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with the Ellipse IM HTO Nail system for osteoarthritis and varus malalignment of the knee.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Dahl, MD | University of Minnesota | Principal Investigator |
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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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| Participants will be followed for the duration of consolidation (bone healing), an average of 4 months |
| Change in Weight-Bearing Line | Measured in percent | 1-year post-operative |
| Change in Weight-Bearing Line | Measured in percent | 2-years post-operative |
| Change in Hip-Knee-Ankle Angle | Measured in degrees | Participants will be followed for the duration of correcting their deformity, an average of 3 weeks |
| Change in Hip-Knee-Ankle Angle | Measured in degrees | Participants will be followed for the duration of consolidation (bone healing), an average of 4 months |
| Change in Hip-Knee-Ankle Angle | Measured in degrees | 1-year post-operative |
| Change in Hip-Knee-Ankle Angle | Measured in degrees | 2-years post-operative |
| Change in Tibial Slope | Measured in degrees | Participants will be followed for the duration of correcting their deformity, an average of 3 weeks |
| Change in Tibial Slope | Measured in degrees | Participants will be followed for the duration of consolidation (bone healing), an average of 4 months |
| Change in Tibial Slope | Measured in degrees | 1-year post-operative |
| Change in Tibial Slope | Measured in degrees | 2 years post-operative |
| Time to full weight-bearing | Measured in days | Participants will be followed through 2 years post-operative |
| Bone Healing | Graded 0 through 2, corresponding to Not Healing, Healing, and Healed | Participants will be followed for the duration of correcting their deformity, an average of 3 weeks |
| Bone Healing | Graded 0 through 2, corresponding to Not Healing, Healing, and Healed | Participants will be followed for the duration of consolidation (bone healing), an average of 4 months |
| Bone Healing | Graded 0 through 2, corresponding to Not Healing, Healing, and Healed | 1-year post-operative |
| Bone Healing | Graded 0 through 2, corresponding to Not Healing, Healing, and Healed | 2 years post-operative |
| Participants will be followed through 2 years post-operative |
| Secondary surgical procedures | Participants will be followed through 2 years post-operative |
| Surgical complications | Participants will be followed through 2 years post-operative |