Limb Length Discrepancy Clinical Trial
— PINSOfficial title:
A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System
Verified date | January 2018 |
Source | Ellipse Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 32 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Loma Linda University | Loma Linda | California |
United States | Hospital for Special Surgery | New York | New York |
United States | Nemours Children's Hospital | Orlando | Florida |
United States | Paley Advanced Limb Lengthening Institute | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Ellipse Technologies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | ||
Secondary | Number of days to complete full weight bearing | Up to an expected average of 99 days. | ||
Secondary | 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 | ||
Secondary | Adverse Events | Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months | ||
Secondary | Device-related complications | Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months | ||
Secondary | Procedure-related complications | Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months |
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