Ellipse Intramedullary Nail High Tibial Osteotomy Study

Study Overview
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Brief Summary
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This study further evaluates the safety profile and efficacy of the Ellipse IM HTO Nail system in subjects with osteoarthritis and varus malalignment of the knee. All subjects will receive treatment with the Ellipse IM HTO Nail System and followed for six months.

Detailed Description
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The Ellipse IM HTO Nail is intended for open wedge proximal tibial osteotomies. The Ellipse IM HTO Nail is an intramedullary nail that operates on the principles of distraction osteogenesis. The Ellipse IM HTO Nail is used in valgizing HTO procedures to correct varus malalignment. The Ellipse IM HTO Nail is surgically placed in the intramedullary canal of the tibia. It is lengthened telescopically using the non-invasive external remote control.

Official Title
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A Multicenter Study of Patients Treated With the Ellipse Technologies Intramedullary High Tibial Osteotomy (IM HTO) Nail System for Osteoarthritis and Varus Malalignment of the Knee

Conditions
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Osteoarthritis, Varus Malalignment

Intervention / Treatment
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* Device: Ellipse IM HTO Nail


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has standing varus malalignment benefitting from high tibial osteotomy correction Patient is diagnosed with current osteoarthritis of the knee Patient is eighteen years of age or greater Patient is a candidate to be implanted with an Ellipse IM HTO System If female of childbearing potential, patient presents with a negative pregnancy test and agrees to employ adequate birth control measures for the duration of the study Patient understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements Patient signs informed consent for the use of their personal private data Exclusion Criteria: Patient declines to sign informed consent for the use of their personal private data Varus deformity greater than 10° Flexion contracture greater than 15° Knee flexion under 90° Medial/lateral tibial subluxation over 1 cm Medial bone loss of over 3 mm Inflammatory arthritis Arthritis in the lateral compartment Patella baja Weight over 114 kg Severe patellofemoral symptoms Unaddressed ligamentous instability Fixed flexion contracture Known or suspected osteoporosis or osteopenia based on medical history and radiographic images Current use of nicotine products. Requires other surgical procedures at the time of the HTO surgery

Ages Eligible for Study
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Minimum Age: 18 Years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IM HTO Nail<br>Implant with the Ellipse IM HTO Nail | Device: Ellipse IM HTO Nail<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-Bearing Line at Final Correction within ±5, 10, and 15% of Baseline Target |  | Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Difference in Weight-Bearing Line Final Target versus Actual at Final Consolidation |  | Week 6 (Considered the Final Correction Visit unless additional visits are required), Month 6 (Considered the Final Consolidation Visit unless additional visits are required) | 
| Absolute Difference in Weight-Bearing Line Baseline Target versus Final Target | Baseline Target versus Final Target | Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required) | 
| Change in Hip-Knee-Ankle Angle Baseline versus Final Correction | Baseline versus Final Correction | Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required) | 
| Change in Hip-Knee-Ankle Angle Baseline versus Final Consolidation |  | Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required) | 
| Change in Tibial Slope Angle Baseline versus Final Correction | Baseline versus Final Correction | Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required) | 
| Change in Tibial Slope Angle Baseline versus Final Consolidation | Baseline versus Final Consolidation | Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required) | 
| Time to Full Weight-Bearing | Amount of time required until a patient is allowed to put 100% of their body weight on the leg. | Week 2, Week 4, Week 6, Month 3, Month 6 |