Lung Regeneration After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis

Scoliosis Idiopathic Adolescent Clinical Trial

Official title:

Lung Regeneration After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539770
• Other study ID #: CIN_LungRegenAIS_001
• Status: Completed
• Start date: November 1, 2014
• Est. completion date: May 31, 2018

Study information

• Verified date: July 2018
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic Adolescent

Intervention

Procedure:
• Posterior spinal fusion
Surgical procedure that involves placement of spinal rods to correct spinal curvature

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alveolar Size	Calculated mean linear intercept as determined by diffusion measurements in HHe MRI	Before posterior spinal fusion and one year after
Secondary	Change in Lung Volume	Measured right and left lung volumes as measured by proton MRI	Before posterior spinal fusion and one year after
Secondary	Change in Alveolar Number	Estimated number of alveoli in right and left lung as calculated from alveolar size and lung volume measures	Before posterior spinal fusion and one year after
Secondary	Altered Alveolar Size in AIS	Determine differences in mean linear intercept (MLI) as determined by HHe diffusion measurements in AIS vs control and AIS right vs left lung	1 day
Secondary	Differences in Lung Volume in AIS	Determine differences in lung volume as determined by proton MRI in AIS vs control and AIS right vs left lung	1 day
Secondary	Differences in Alveolar Number in AIS	Determine differences in estimated alveolar number as calculated using MLI and lung volume measures in AIS vs control and AIS right vs left lung	1 day