Clinical trial NCT01601301: Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System
Official title: A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Limb Length Discrepancy
Keywords: Limb
Lengthening
PRECICE
Ellipse
Technologies
Distraction
Osteogenesis
Femur
Tibia
Intramedullary
Nail
Device
Medical
Orthopedic
Implant
Lead sponsor: Ellipse Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-18
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Bone Union
timeFrame: 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
measure: Pain
timeFrame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
measure: Healing Index
timeFrame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
measure: Number of days to complete lengthening
timeFrame: Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days
measure: Number of days to complete full weight bearing
timeFrame: Up to an expected average of 99 days.
measure: Number of days to full consolidation
timeFrame: 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
measure: Adverse Events
timeFrame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
measure: Device-related complications
timeFrame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
measure: Procedure-related complications
timeFrame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: West Palm Beach
country: United States
facility: Paley Advanced Limb Lengthening Institute
state: Florida
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: University of California, Irvine
name: Stuart A Green, MD
role: PRINCIPAL_INVESTIGATOR
References: