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Lung Regeneration After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539770
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
Adolescent Idiopathic Scoliosis (AIS) is a curvature of the spine that occurs in 1-2% of otherwise healthy children, and requires corrective surgery, posterior spinal fusion (PSF) in ~10% of cases. Some studies suggest that pulmonary function is reduced in AIS and that PSF improves pulmonary function. The lung is composed of a large number of branching airways that terminate in gas exchanging units called alveoli, and the number and structure of these alveoli are partially dependent upon lung volume and the forces to which they are exposed--two factors predicted to be altered in AIS. This study uses MRI imaging of inhaled helium to quantify alveolar structure in children with and without AIS before and one-year after PSF. The goals of the study are to determine if alveolar architecture or number are altered in AIS and whether PSF impacts these same measures.

Condition or disease Intervention/treatment
Scoliosis Idiopathic Adolescent Procedure: Posterior spinal fusion

Detailed Description:
After obtaining informed consent, subjects are trained in a breath holding technique that permits obtaining reproducible proton and hyperpolarized helium (HHE) lung images. 3-Helium is obtained from a vendor and hyperpolarized using an optical spin transfer device (FDA Investigational New Drug (IND) 122,670) and administered through a valved inhalation device while in the MRI scanner. Images are obtained during an ~15 second inspiratory breath hold. Proton MRI images are similarly obtained during a breath hold with room air using an ultrashort echo time sequence. From these MRI images, lung volumes, alveolar sizes, and estimated alveolar numbers are derived. Subjects are reimaged at 1 year to evaluate changes in these parameters during normal lung growth (controls) or after PSF (AIS subjects).

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Lung Regeneration After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort Intervention/treatment
AIS
Adolescent idiopathic scoliosis subjects undergoing posterior spinal fusion.
Procedure: Posterior spinal fusion
Surgical procedure that involves placement of spinal rods to correct spinal curvature

Control
Children without scoliosis



Primary Outcome Measures :
  1. Change in Alveolar Size [ Time Frame: Before posterior spinal fusion and one year after ]
    Calculated mean linear intercept as determined by diffusion measurements in HHe MRI


Secondary Outcome Measures :
  1. Change in Lung Volume [ Time Frame: Before posterior spinal fusion and one year after ]
    Measured right and left lung volumes as measured by proton MRI

  2. Change in Alveolar Number [ Time Frame: Before posterior spinal fusion and one year after ]
    Estimated number of alveoli in right and left lung as calculated from alveolar size and lung volume measures

  3. Altered Alveolar Size in AIS [ Time Frame: 1 day ]
    Determine differences in mean linear intercept (MLI) as determined by HHe diffusion measurements in AIS vs control and AIS right vs left lung

  4. Differences in Lung Volume in AIS [ Time Frame: 1 day ]
    Determine differences in lung volume as determined by proton MRI in AIS vs control and AIS right vs left lung

  5. Differences in Alveolar Number in AIS [ Time Frame: 1 day ]
    Determine differences in estimated alveolar number as calculated using MLI and lung volume measures in AIS vs control and AIS right vs left lung



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy control and otherwise healthy AIS children and young adults
Criteria

Inclusion Criteria:

  1. Be diagnosed with AIS.
  2. Have a Cobb Angle > 50°.
  3. Be recommended for PSF.
  4. Be between the ages of 8 and 21 years old (inclusive) at the time of surgery.
  5. Be able to perform the required 10 second inspiratory hold and remain lying still for that time period without the need for sedative medication (as assessed at time of enrollment).
  6. Have a primary caregiver who agrees to attend all required points of contact for this study (if under the age of 18).

Exclusion Criteria:

  1. Have had a previous spinal surgery.
  2. Have other planned major surgeries during the study period.

    a. Minor surgeries such as G-tube revisions or dental procedures are permissible.

  3. Have or had a history of any chronic lung disease apart from restrictive lung disease from scoliosis (e.g.

    cystic fibrosis, bronchopulmonary dysplasia, asthma, etc.).

  4. Have a personal history of smoking
  5. Require any supplemental oxygen at baseline. Home Biphasic Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) is acceptable provided the participant can perform the required breath holds without these devices.
  6. Have been born at <35 weeks gestational age.
  7. Received mechanical ventilation in the first year of life.
  8. Have a room air oxygen saturation of less than 95%.
  9. Have any implanted metal device or hardware (apart from future orthopaedic hardware).
  10. Be likely to move out of the Cincinnati area before the one year follow-up appointment.

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): NCT03539770


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03539770    
Other Study ID Numbers: CIN_LungRegenAIS_001
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We would be willing to share individual participant data with researchers who request the data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Lung Development
Lung Regeneration
Hyperpolarized Helium
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases