First in Man Study - A Prospective, Multicenter, Single Arm Trial to Investigate the Safety and Feasibility of the PRECICE 8.5mm Intramedullary Limb Lengthening System with Leg Length Discrepancy Due to a Short Femur or Tibia

Ellipse Technologies, Inc.0 个研究点目标入组 10 人开始时间: 2013年6月11日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1.Leg length discrepancy greater than or equal to 1.5 cm and less than or equal to 8.0 cm due to short femur or tibia
•2.Age greater than or equal to 7 years old
•3.Weight less than or equal to 68 kg
•4.Intramedullary canal without offset
•5.Tibia or femur sufficient to contain the implant
•6.Availability, willingness, and sufficient cognitive awareness to comply with protocol procedures and schedule
•7.Must sign informed consent to permit the use of personal health data

•1.Active infection or previous history of deep infection in the involved bone
•2.Metal allergies or sensitivities to the components of the device
•3.Distance from the nearest convenient external surface of the treated limb to the intramedullary canal < 51 mm
•4.Significant range of motion deficit of the adjacent joints
•5.Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic or magnetic implant
•6.Patients who require an MRI during implantation
•7.Non-union
•8.Impassable or obstructed intramedullary canal
•9.Significant angular deformity that prevents device placement
•10.Cannot bear weight on the contralateral limb
•11.Procedural osteotomy cannot be made in an appropriate location
•12.Deformities that require multilevel osteotomies or bi-lateral implantation at the time of study index surgery
•13.Systemic bone disease
•14.Pregnant or nursing women
•15.Inadequate vascularity or evidence of vascular disease or peripheral neuropathy
•16.Malignancies or tumors in the involved bone
•17.Patient is a drug abuser
•18.Open wounds or ulcers that could compromise treatment

发起方