NCT07734467

Brief Summary

The objective of this study is to evaluate the immune response to posterior spinal fusion (PSF) in patients with neuromuscular scoliosis, comparing patients with idiopathic scoliosis who undergo the same procedure. This will be accomplished using serum biomarkers of immune response. Anecdotally, it appears that patients with neuromuscular scoliosis have more fluid resuscitation needs compared to patients with idiopathic scoliosis. The proposed hypothesis of this observation is that patients with neuromuscular scoliosis have a more profound immune response compared to patients with idiopathic scoliosis, which leads to a more robust systematic inflammatory response syndrome.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
39mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

2.7 years

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Posterior Spinal FusionIdiopathic ScoliosisNeuromuscular Scoliosis

Outcome Measures

Primary Outcomes (1)

  • Immune response to posterior spinal fusion in patients with neuromuscular scoliosis compared to patients with idiopathic scoliosis

    Blood samples to determine serum immunophenotyping using cytokine profiles for immune response testing.

    From enrollment to approximately one hour after surgery completion.

Study Arms (2)

Neuromuscular scoliosis

ACTIVE COMPARATOR

Patients with neuromuscular scoliosis undergoing posterior spinal fusion

Diagnostic Test: Serum blood samples for serum biomarkers of immune response

Idiopathic scoliosis

ACTIVE COMPARATOR

Patients with idiopathic scoliosis undergoing posterior spinal fusion

Diagnostic Test: Serum blood samples for serum biomarkers of immune response

Interventions

Serum blood samples for serum biomarkers of immune responseDIAGNOSTIC_TEST

Preoperative and postoperative blood samples using biomarkers to evaluate immune response.

Idiopathic scoliosisNeuromuscular scoliosis

Eligibility Criteria

Age0 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient undergoing a posterior spinal fusion, regardless of age (birth to adult)
  • any patient with a diagnosis of idiopathic or neuromuscular scoliosis

You may not qualify if:

  • Patient taking immunomodulators (monoclonal antibodies, chemotherapeutic agents)
  • chronic steroid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

  • Ambrish Patel, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Roth

CONTACT

614-722-2997catherine.roth@nationwidechildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Physician - Pediatric Anesthesiology & Pediatric Critical Care

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 29, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

July 29, 2026

Record last verified: 2026-07

Locations

US(1)