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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ellipse Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
Ellipse Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01601301
First received: May 14, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the performance and safety of the Ellipse PRECICE Intramedullary Limb Lengthening System.


Condition Intervention Phase
Limb Length Discrepancy
Device: PRECICE System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System

Further study details as provided by Ellipse Technologies, Inc.:

Primary Outcome Measures:
  • Distraction Control: actual distraction rate vs. target distraction rate [ Time Frame: Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone Union [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months ] [ Designated as safety issue: No ]
    Pain measured by the SF-36v2, American Academy of Orthopaedic Surgeons Lower Limb Outcomes Questionnaire, and medication use.

  • Healing Index [ Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days ] [ Designated as safety issue: No ]
  • Number of days to complete full weight bearing [ Time Frame: Up to an expected average of 99 days. ] [ Designated as safety issue: No ]
  • Number of days to full consolidation [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months ] [ Designated as safety issue: Yes ]
  • Device-related complications [ Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months ] [ Designated as safety issue: Yes ]
  • Procedure-related complications [ Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRECICE Treatment
All qualifying subjects enrolled are to be treated with the PRECICE Intramedullary Limb Lengthening System
Device: PRECICE System
PRECICE System implantation into the subject's femur or tibia

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Leg length discrepancy ≥ 1.5 cm and ≤ 6.5 cm due to short femur or tibia
  • Weight ≤ 114 kg
  • 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 > 51 mm for the 10.7 mm PRECICE System or > 76 mm for the 12.5 mm PRECICE System
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601301

Contacts
Contact: Chris Hafner 949-837-3600 chafner@ellipse-tech.com

Locations
United States, California
Loma Linda University Active, not recruiting
Loma Linda, California, United States, 92350
United States, Florida
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Shannon Henry, MA, CCRC    407-650-7604    shannon.henry@nemours.org   
Principal Investigator: Christopher Iobst, MD         
Paley Advanced Limb Lengthening Institute Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Pamela Beck    561-495-3238    Pamela.Beck@tenethealth.com   
Contact: Sarah Ziegler    (561) 882-4571    sziegler@lengthening.us   
Principal Investigator: Dror Paley, MD         
United States, Maryland
Sinai Hospital of Baltimore Active, not recruiting
Baltimore, Maryland, United States, 21215
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Eugene Borst, BA    646-797-8249    borste@hss.edu   
Principal Investigator: Robert Rozbruch, MD         
Sub-Investigator: Austin Fragomen, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Emily Eismann    513-803-1603    Emily.Eismann@cchmc.org   
Principal Investigator: James McCarthy, MD         
Sponsors and Collaborators
Ellipse Technologies, Inc.
Investigators
Principal Investigator: Stuart A Green, MD University of California, Irvine
  More Information

Additional Information:
No publications provided

Responsible Party: Ellipse Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01601301     History of Changes
Other Study ID Numbers: Ellipse-0035
Study First Received: May 14, 2012
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ellipse Technologies, Inc.:
Limb
Lengthening
PRECICE
Ellipse
Technologies
Distraction
Osteogenesis
Femur
Tibia
Intramedullary
Nail
Device
Medical
Orthopedic
Implant

ClinicalTrials.gov processed this record on August 28, 2014