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

January 31, 2018 updated by: Ellipse Technologies, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University
    • Florida
      • Orlando, Florida, United States, 32827
        • Nemours Children's Hospital
      • West Palm Beach, Florida, United States, 33407
        • Paley Advanced Limb Lengthening Institute
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PRECICE System
Device: PRECICE System
Lenthening of either the tibia or femur with the PRECICE System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Time Frame: 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.
Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Healing Index
Time Frame: 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.
Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
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
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
Time Frame: Up to an expected average of 99 days.
Up to an expected average of 99 days.
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
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
Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Device-related complications
Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Procedure-related complications
Time Frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ellipse Technologies, Inc.

Investigators

  • Principal Investigator: Stuart A Green, MD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (ESTIMATE)

May 18, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR0035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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