Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System (NCT01601301) | Clinical Trial Compass
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Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System
United States32 participantsStarted 2012-07
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Pregn…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Distraction Control: actual distraction rate vs. target distraction rate
Timeframe: Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days