Ellipse IM HTO Study
Research type
Research Study
Full title
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.
IRAS ID
178084
Contact name
Michael McNicholas
Contact email
Sponsor organisation
Ellipse Technologies, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 8 days
Research summary
This study is being done to gain clinical experience for the Ellipse Intramedullary High Tibial Osteotomy (IM HTO) Nail System for subjects with knee osteoarthritis and varus malalignment of the knee (bowed legs). The data gathered in this study will be used to further evaluate the safety and efficacy of IM HTO nail.
Ellipse Technologies has developed the IM HTO Nail system that has received CE-Mark on 27 October 2014. The system consists of the intramedullary nail (a nail that goes along the centre of the bone), locking screws, external remote controller, and instrument and accessory tray. The IM HTO nail is surgically placed in the intramedullary canal of the tibia and is lengthened or shortened telescopically using the non-invasive external remote controller. As a result, the osteotomy can be distracted (moving the two segments of bone slowly apart in such a way that new bone fills in the gap) or compressed using the principles of distraction osteogenesis with precise control on the rate and amount of lengthening or compression. This allows for accurate and customisable correction of malalignment of the knee during the course of the treatment. The new bone growth formed during the correction of the osteotomy allows the patient to avoid undergoing a bone graft harvesting procedure typically required for open wedge high tibial osteotomies.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0430
Date of REC Opinion
17 Jul 2015
REC opinion
Further Information Favourable Opinion