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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Lenthening of either the tibia or femur with the PRECICE System.
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
Distraction Control: actual distraction rate vs. target distraction rate
Time frame: Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days
Bone Union
Time frame: 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
Pain measured by the SF-36v2, American Academy of Orthopaedic Surgeons Lower Limb Outcomes Questionnaire, and medication use.
Time frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Healing Index
The total treatment period with the PRECICE System in situ, divided by the length of bone growth in centimeters.
Time frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Number of days to complete lengthening
Time frame: Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days
Number of days to complete full weight bearing
Time frame: Up to an expected average of 99 days.
Number of days to full consolidation
Time frame: 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
Adverse Events
Time frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital for Special Surgery
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Device-related complications
Time frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Procedure-related complications
Time frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months