Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System

Status unconfirmed · Not applicable

Conditions studied: Limb Length Discrepancy

In brief

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 lengthening.

Key facts

Study ID

NCT01601301

Run by

Ellipse Technologies, Inc.

People needed

32

Starts

2012-07-01

Expected to finish

2018-06-01

Last updated by the study team

2018-02-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Skeletally mature
• 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

You may not qualify if…

• 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
• Non-union
• 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

Where it is running

• Loma Linda University — Loma Linda, California, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Paley Advanced Limb Lengthening Institute — West Palm Beach, Florida, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Hospital for Special Surgery — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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