None listed
Conditions
Brief summary
To obtain safety and feasibility data of the Ellipse PRECICE 8.5mm Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.
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 ident
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.
Sponsors
Ellipse Technologies, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed