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.
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.
Study Type
OBSERVATIONAL
Enrollment
41
Medizinische Hochschule
Hanover, Germany
Martini Ziekenhuis
Groningen, Netherlands
Isala Klinieken
Zwolle, Netherlands
Centrum Ortopedii I Traumatologii
Weight-Bearing Line at Final Correction within ±5, 10, and 15% of Baseline Target
Time frame: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
Absolute Difference in Weight-Bearing Line Final Target versus Actual at Final Consolidation
Time frame: 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
Time frame: 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
Time frame: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
Change in Hip-Knee-Ankle Angle Baseline versus Final Consolidation
Time frame: 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
Time frame: 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
Time frame: Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
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Bialystok, Poland
Zagiel Hospital
Lublin, Poland
Lekmed Hospital
Warsaw, Poland
District Hospital of Wolomin
Wołomin, Poland
North Bristol NHS Trust
Bristol, United Kingdom
North Cumbria University Hospital
Carlisle, United Kingdom
University Hospital Aintree
Liverpool, United Kingdom
...and 1 more locations
Time to Full Weight-Bearing
Amount of time required until a patient is allowed to put 100% of their body weight on the leg.
Time frame: Week 2, Week 4, Week 6, Month 3, Month 6