NCT02412163

Ellipse Intramedullary Nail High Tibial Osteotomy Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Ellipse Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Osteoarthritis
• Varus Malalignment

Interventions

Type	Name	Description
DEVICE	Ellipse IM HTO Nail

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-07-01
• Completion: 2016-12-01
• First posted: 2015-04-09
• Last updated: 2017-09-01

Locations

11 sites across 4 countries: Germany, Netherlands, Poland, United Kingdom

Regulatory

• FDA-regulated device study