NCT03539770|CompletedFDA Drug
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Sponsor study identifier
observational
29
1 country
1
Study Start
November 1, 2014
Actual (reported)Primary Completion
May 31, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2014
Actual (reported)May 16, 2018
Actual (reported)May 29, 2018
Actual (reported)May 31, 2018
Actual (reported)May 31, 2018
Actual (reported)Change in Alveolar Size
Calculated mean linear intercept as determined by diffusion measurements in HHe MRI
Before posterior spinal fusion and one year after
Change in Lung Volume
Before posterior spinal fusion and one year after
Change in Alveolar Number
Before posterior spinal fusion and one year after
Altered Alveolar Size in AIS
1 day
Differences in Lung Volume in AIS
1 day
Differences in Alveolar Number in AIS
1 day
Adolescent idiopathic scoliosis subjects undergoing posterior spinal fusion.
Children without scoliosis
Surgical procedure that involves placement of spinal rods to correct spinal curvature
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthy control and otherwise healthy AIS children and young adults
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Thomen RP, Woods JC, Sturm PF, Jain V, Walkup LL, Higano NS, Quirk JD, Varisco BM. Lung microstructure in adolescent idiopathic scoliosis before and after posterior spinal fusion. PLoS One. 2020 Oct 8;15(10):e0240265. doi: 10.1371/journal.pone.0240265. eCollection 2020.
29 participants (actual enrollment reported by the registry).
First Submitted
May 16, 2018
First Posted
May 29, 2018
Study Start
November 1, 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
May 31, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)Last Updated
July 24, 2018
Record last verified: 2018-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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