Immune Response to PSF for Scoliosis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Ambrish Patel, MD
Principal Investigator
Nationwide Children's Hospital
Are You a Good Fit for This Trial?
This trial is for people with either idiopathic scoliosis or neuromuscular scoliosis who are scheduled to have posterior spinal fusion surgery. Specific inclusion and exclusion criteria are not listed, but participants must be able to provide blood samples.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Blood sample obtained prior to incision for immunophenotyping using cytokine profiles
Post-operative
Blood sample obtained in PACU or PICU for post-operative immunophenotyping
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares the immune response after spinal fusion surgery between patients with idiopathic and neuromuscular scoliosis by analyzing blood samples for immune markers. No new drugs or treatments are being tested.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients with neuromuscular scoliosis undergoing posterior spinal fusion
Patients with idiopathic scoliosis undergoing posterior spinal fusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ambrish Patel
Lead Sponsor
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