Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System

Study Overview
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Brief Summary
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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
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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

Official Title
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A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System

Conditions
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Limb Length Discrepancy

Intervention / Treatment
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* Device: PRECICE System


Participation Criteria
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Eligibility Criteria
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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 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRECICE System<br> | Device: PRECICE System<br>* Lenthening of either the tibia or femur with the PRECICE System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Pain measured by the SF-36v2, American Academy of Orthopaedic Surgeons Lower Limb Outcomes Questionnaire, and medication use. | 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. | Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months | 
| 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 | 
| 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 | 
| Adverse Events |  | Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months | 
| Device-related complications |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Limb, Lengthening, PRECICE, Ellipse, Technologies, Distraction, Osteogenesis, Femur, Tibia, Intramedullary, Nail, Device, Medical, Orthopedic, Implant