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
SexALL
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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…
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