Scoliosis Idiopathic AdolescentNCT03539770
Lung Regeneration After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
An observational study of Scoliosis Idiopathic Adolescent, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent
- What is being tested?
- Posterior spinal fusion
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Healthy control and otherwise healthy AIS children and young adults
Who may be able to join
- 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).
Who cannot join
- Have had a previous spinal surgery.
- Have other planned major surgeries during the study period.
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
Read the 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).
- Conditions
- Scoliosis Idiopathic Adolescent
- Being tested
- Posterior spinal fusion
- Keywords
- Lung Development, Lung Regeneration, Hyperpolarized Helium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior spinal fusionProcedure or surgery
Surgical procedure that involves placement of spinal rods to correct spinal curvature
| Study group | Role | What they receive |
|---|---|---|
| AIS | Adolescent idiopathic scoliosis subjects undergoing posterior spinal fusion. Receives: Procedure: Posterior spinal fusion | |
| Control | Children without scoliosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alveolar Size
Calculated mean linear intercept as determined by diffusion measurements in HHe MRI
Measured: Before posterior spinal fusion and one year after
Secondary outcomes (5)
Change in Lung Volume
Measured right and left lung volumes as measured by proton MRI
Measured: Before posterior spinal fusion and one year after
Change in Alveolar Number
Estimated number of alveoli in right and left lung as calculated from alveolar size and lung volume measures
Measured: Before posterior spinal fusion and one year after
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
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Nov 2014
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scoliosis Idiopathic AdolescentStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539770
- Sponsor's protocol ID
- CIN_LungRegenAIS_001
- Status last verified
- Jul 2018
- First submitted
- 16 May 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We would be willing to share individual participant data with researchers who request the data.
Publications
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.
PubMed 33031412
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Regeneration After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03539770
- Acronym / sponsor ID
- CIN_LungRegenAIS_001
- Conditions
- Scoliosis Idiopathic Adolescent
- Keywords
- Lung Development, Lung Regeneration, Hyperpolarized Helium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIS | – | Procedure: Posterior spinal fusionAdolescent idiopathic scoliosis subjects undergoing posterior spinal fusion. |
| Control | – | –Children without scoliosis |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Healthy control and otherwise healthy AIS children and young adults
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (12 listed)
- Have had a previous spinal surgery.
- Have other planned major surgeries during the study period.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior spinal fusionSurgical procedure that involves placement of spinal rods to correct spinal curvature | Procedure or surgery | AIS |
Primary outcome
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
5 secondary outcomes
Change in Lung Volume
Time frame: Before posterior spinal fusion and one year after
Change in Alveolar Number
Time frame: Before posterior spinal fusion and one year after
Altered Alveolar Size in AIS
Time frame: 1 day
Differences in Lung Volume in AIS
Time frame: 1 day
Differences in Alveolar Number in AIS
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Derived from this study: PubMed 33031412Thomen 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.
- Individual participant dataSharing planned: Undecided. We would be willing to share individual participant data with researchers who request the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic Adolescent, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alveolar Size (time frame: Before posterior spinal fusion and one year after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.