Limb Length Discrepancy
Conditions
Keywords
Limb, Lengthening, PRECICE, Ellipse, Technologies, Distraction, Osteogenesis, Femur, Tibia, Intramedullary, Nail, Device, Medical, Orthopedic, Implant
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
Interventions
DEVICEPRECICE System
Lenthening of either the tibia or femur with the PRECICE System.
Sponsors
Ellipse Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. | — |
| 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 | — |
| 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 | — |
| 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 | — |
Countries
United States
Outcome results
None listed