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Vertical Expandable Prosthetic Titanium Rib (VEPTR) for Thoracic Insufficiency Syndrome (VEPTR)

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ClinicalTrials.gov Identifier: NCT02241954
Recruitment Status : Enrolling by invitation
First Posted : September 16, 2014
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Martus, Vanderbilt University Medical Center

Brief Summary:

The hypothesis of the study is that individuals with poor pulmonary function secondary to TIS will benefit from expansion thoracoplasty. The investigators specific aims are to:

  1. Record pulmonary function and thoracic volume of TIS patients at enrollment and with serial observation
  2. Offer expansion thoracoplasty therapy to TIS patients with

    1. poor pulmonary function at enrollment
    2. progressive decline in pulmonary function
    3. progressive chest wall and/or spinal deformity
    4. lack of appropriate increase in thoracic volume during growth
  3. Document efficacy of expansion thoracoplasty for TIS patients

Condition or disease Intervention/treatment
Thoracic Insufficiency Syndrome (TIS) Device: Synthes VEPTR (Vertical Expandable Prosthetic Titanium Rib)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ertical Expandable Prosthetic Titanium Rib (VEPTR) for Thoracic Insufficiency Syndrome
Study Start Date : January 2010
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Group/Cohort Intervention/treatment
Expansion Thoracoplasty
The rib prosthesis is lengthened periodically to correct the concavity of the deformity, expanding the volume of the hypoplastic thorax and improving associated spinal deformity. This device has been FDA approved by a Humanitarian Device Exemption and is described as a Vertical Expandable Prosthetic Titanium Rib (VEPTR). An updated version of the VEPTR, the VEPTR II, may be used instead depending on the physician's preference and the patient's anatomy. The VEPTR II device has greater size range and modularity of implants than the original VEPTR.
Device: Synthes VEPTR (Vertical Expandable Prosthetic Titanium Rib)



Primary Outcome Measures :
  1. Pulmonary function and thoracic volume of TIS patients [ Time Frame: Enrollment (Baseline), Serial Observation Postop (Change from baseline at: 6 week, 12 week, 6 month, and every 6 months after that.) ]
    1)Record pulmonary function and thoracic volume of TIS patients at enrollment and with serial observation postoperatively (Change from baseline at: 6 week, 12 week, 6 month, and every 6 months after that.)

  2. ffer expansion thoracoplasty therapy to TIS patients meeting certain criteria (provided in description below) [ Time Frame: Enrollment (Baseline), Serial Observation Postop (Change from baseline at: 6 week, 12 week, 6 month, and every 6 months after that.) ]

    Offer expansion thoracoplasty therapy to TIS patients with

    • poor pulmonary function at enrollment
    • progressive decline in pulmonary function
    • progressive chest wall and/or spinal deformity
    • lack of appropriate increase in thoracic volume during growth

  3. Document efficacy of expansion thoracoplasty for TIS patients [ Time Frame: Enrollment (Baseline), Serial Observation Postop (Change from baseline at: 6 week, 12 week, 6 month, and every 6 months after that.) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients, age range from 6 months to 17 years with thoracic insufficiency syndrome (TIS). Categories of TIS include:

  1. Flail chest syndrome
  2. Constrictive chest wall syndrome (rib fusions and scoliosis)
  3. Hypoplastic thorax syndrome (Jeune's syndrome, achondroplasia, Jarcho-levin syndrome, Ellis van Creveld syndrome)
  4. Progressive scoliosis/kyphosis of congenital, neurogenic, or idiopathic origin without rib anomaly
  5. Early onset scoliosis without rib anomaly at high risk for progression
Criteria

Inclusion Criteria:

  • Pediatric patients, age range from 6 months - 17 years with thoracic insufficiency syndrome (TIS) will be considered for inclusion. Categories of TIS include:

    1. Flail chest syndrome
    2. Constrictive chest wall syndrome (rib fusions and scoliosis)
    3. Hypoplastic thorax syndrome (Jeune's syndrome, achondroplasia, Jarcho-levin syndrome, Ellis van Creveld syndrome)
    4. Progressive scoliosis/kyphosis of congenital, neurogenic, or idiopathic origin without rib anomaly
    5. Early onset scoliosis without rib anomaly at high risk for progression

Exclusion Criteria:

  • Failure to meet inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241954


Locations
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United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Jeffrey Martus, MD Vanderbilt University Medical Center

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Responsible Party: Jeffrey Martus, Assistant Professor of Orthopaedics, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02241954     History of Changes
Other Study ID Numbers: 091371
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes