Ellipse Intramedullary High Tibial Osteotomy Nail Study

Study Overview
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Brief Summary
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The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.

Official Title
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Outcomes Registry of Patients With Osteoarthritis and Varus Malalignment of the Knee Treated With Ellipse Intramedullary High Tibial Osteotomy (IM HTO) Nail System

Conditions
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Osteoarthritis, Varus Malalignment

Intervention / Treatment
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* Device: Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient implanted with the Ellipse IM HTO Nail System for osteoarthritis and varus malalignment of the knee Patient signs informed consent for the use of their personal private data. Exclusion Criteria: Patient is currently enrolled in another clinical trial for high tibial osteotomy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |