The purpose of this study is to obtain post market performance and safety data of the Ellipse
PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb
Device: PRECICE System
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01601301
Ages eligible for Study
Genders eligible for Study
Accepts Healthy Volunteers
Leg length discrepancy ≥ 1.5 cm and ≤ 6.5 cm due to short femur or tibia
Weight ≤ 114 kg if implanted with the 10.7 mm or 12.5 mm diameter nail, or ≤ 57 kg if implanted with the 8.5 mm diameter nail
Intramedullary canal without offset
Tibia or femur sufficient to contain the implant
Availability, willingness, and sufficient cognitive awareness to comply with protocol procedures and schedule
Must sign informed consent to permit the use of personal health data
Active infection or previous history of deep infection in the involved bone
Metal allergies or sensitivities to the components of the device
Distance from the nearest convenient external surface of the treated limb to the intramedullary canal > 38 mm for the 8.5 mm PRECICE nail, > 51 mm for the 10.7 mm PRECICE nail, or > 76 mm for the 12.5 mm PRECICE nail
Significant range of motion deficit of the adjacent joints
Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic or magnetic implant
Patients who require an MRI during implantation
Impassable or obstructed intramedullary canal
Significant angular deformity that prevents device placement
Cannot bear weight on the contralateral limb
Procedural osteotomy cannot be made in an appropriate location
Deformities that require multilevel osteotomies or bi-lateral implantation at the time of study index surgery
Systemic bone disease
Pregnant or nursing women
Inadequate vascularity or evidence of vascular disease or peripheral neuropathy
Malignancies or tumors in the involved bone
Patient is a drug abuser
Open wounds or ulcers that could compromise treatment
All locations for NCT01601301
United States (6)
Loma Linda University
Loma Linda, California, United States, 92350
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Paley Advanced Limb Lengthening Institute
West Palm Beach, Florida, United States, 33407
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Hospital for Special Surgery
New York, New York, United States, 10021
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
View full eligibility
Tris trial is registered with FDA with number: NCT01601301. The sponsor of the trial is Ellipse Technologies, Inc. and it is looking for 32 volunteers for the current phase.
Official trial title: A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System
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