Lung Regeneration After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis

NCT03539770 | Completed FDA Drug

• 1 other identifier: CIN_LungRegenAIS_001
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Idiopathic Adolescent

Keywords

Lung Development; Lung Regeneration; Hyperpolarized Helium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

AIS

Adolescent idiopathic scoliosis subjects undergoing posterior spinal fusion.

Procedure: Posterior spinal fusion

Control

Children without scoliosis

Interventions

Posterior spinal fusion PROCEDURE

Surgical procedure that involves placement of spinal rods to correct spinal curvature

AIS

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy control and otherwise healthy AIS children and young adults

You may qualify if:

• Be diagnosed with AIS.
• Have a Cobb Angle \> 50°.
• Be recommended for PSF.
• Be between the ages of 8 and 21 years old (inclusive) at the time of surgery.
• 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).
• Have a primary caregiver who agrees to attend all required points of contact for this study (if under the age of 18).

You may not qualify if:

• Have had a previous spinal surgery.
• Have other planned major surgeries during the study period.
• a. Minor surgeries such as G-tube revisions or dental procedures are permissible.
• 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.).
• Have a personal history of smoking
• 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.
• Have been born at \<35 weeks gestational age.
• Received mechanical ventilation in the first year of life.
• Have a room air oxygen saturation of less than 95%.
• Have any implanted metal device or hardware (apart from future orthopaedic hardware).
• Be likely to move out of the Cincinnati area before the one year follow-up appointment.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 33031412 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: November 1, 2014
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

US (1)