Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System
- Conditions
- Limb Length Discrepancy
- Interventions
- Device: PRECICE System
- Registration Number
- NCT01601301
- Lead Sponsor
- Ellipse Technologies, Inc.
- Brief Summary
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.
- Detailed Description
Subject data will be reviewed at the following visits:
* Preoperative
* Operative
* Every 7 to 14 days through Distraction Phase
* Every 4 to 6 weeks through Consolidation Phase
* 6-Month Post-Consolidation
* 12-Month Post-Consolidation
* 18-Month Post-Consolidation
* 24-Month Post-Consolidation
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PRECICE System PRECICE System -
- Primary Outcome Measures
Name Time Method Distraction Control: actual distraction rate vs. target distraction rate Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days
- Secondary Outcome Measures
Name Time Method Number of days to complete lengthening Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days Adverse Events Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months Procedure-related complications Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months Number of days to complete full weight bearing Up to an expected average of 99 days. Number of days to full consolidation Following completion of the subject's distraction regimen, every 4-6 weeks until the subject's treated limb is evaluated as consolidated, an expected average of 66 days Bone Union Following completion of the subject's distraction regimen, every 4-6 weeks until the subject's treated limb is evaluated as consolidated, an expected average of 66 days Pain Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months Pain measured by the SF-36v2, American Academy of Orthopaedic Surgeons Lower Limb Outcomes Questionnaire, and medication use.
Healing Index Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months The total treatment period with the PRECICE System in situ, divided by the length of bone growth in centimeters.
Device-related complications Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Trial Locations
- Locations (6)
Hospital for Special Surgery
🇺🇸New York, New York, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Paley Advanced Limb Lengthening Institute
🇺🇸West Palm Beach, Florida, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Nemours Children's Hospital
🇺🇸Orlando, Florida, United States