Immune Response to PSF in Idiopathic vs Neuromuscular Scoliosis

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ambrish Patel
Study ID
NCT07734467
Status
Not Yet Recruiting

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Conditions

  • Idiopathic Scoliosis
  • Neuromuscular Scoliosis
  • Posterior Spinal Fusion

Eligibility Criteria

Sex
ALL
Age
0 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Serum blood samples for serum biomarkers of immune response — DIAGNOSTIC_TEST
    Preoperative and postoperative blood samples using biomarkers to evaluate immune response.

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Active Comparator: Neuromuscular scoliosis
    Patients with neuromuscular scoliosis undergoing posterior spinal fusion
  • Active Comparator: Idiopathic scoliosis
    Patients with idiopathic scoliosis undergoing posterior spinal fusion

Primary Outcome Measure

Immune response to posterior spinal fusion in patients with neuromuscular scoliosis compared to patients with idiopathic scoliosis [ Time Frame: From enrollment to approximately one hour after surgery completion. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Catherine Roth
[email protected]
614-722-2997
Ambrish Patel, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Nationwide Children's Hospital· Columbus, OH

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