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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ellipse Technologies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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