PRECICE 8.5mm First in Man Study - Intramedullary Limb Lengthening for Patients with a Unilateral Leg Length Discrepancy
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.
10 participants
Jun 17, 2013
Interventional
Conditions
Summary
To obtain safety and feasibility data of the Ellipse PRECICE 8.5mm Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.
Eligibility
Inclusion Criteria7
- 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
- Age greater than or equal to 7 years old
- Weight less than or equal to 68 kg
- 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
Exclusion Criteria18
- 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 < 51 mm
- 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
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Interventions
The PRECICE 8.5mm Intramedullary Limb Lengthening (IMLL) System is indicated for limb lengthening of the tibia and femur. It is composed of an implantable intramedullary device (“IMLL Device”), locking screws, an external remote controller (“ERC”), and reusable instruments. The implantable IMLL Device is available in different configurations and lengths to accommodate a variety of patient anatomies. The PRECICE 8.5mm IMLL System is implanted with a minimally-invasive surgical procedure identical to that of the commercially-approved PRECICE system and similar to other intramedullary limb lengthening devices. The Distraction Phase (lengthening phase) begins after an appropriate latency interval, typically 5 days after surgery. During Distraction Phase, the device is lengthened (typically 1mm per day) until the desired length is achieved depending upon each individual patient's leg length discrepancy. Consolidation Phase begins immediately after distraction phase and ends upon radiographic verification of union (corticalization of bone regenerate observed on 3 sides of the treat bone). Subjects return for study follow-up examinations every 4 to 6 weeks during Consolidation Phase. As with the Distraction Phase, the Consolidation Phase will differ for each patient according to their treatment program as defined by their physician.
Locations(2)
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ACTRN12613000649718