Immune Response to PSF for Scoliosis

CR
Overseen ByCatherine Roth
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Ambrish Patel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

AP

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

I am having a posterior spinal fusion surgery.
I have been diagnosed with idiopathic or neuromuscular scoliosis.

Exclusion Criteria

I am currently taking immunomodulator medications.
I regularly take steroid medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Blood sample obtained prior to incision for immunophenotyping using cytokine profiles

1 day
1 visit (in-person)

Post-operative

Blood sample obtained in PACU or PICU for post-operative immunophenotyping

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Neuromuscular scoliosisExperimental Treatment1 Intervention
Group II: Idiopathic scoliosisExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ambrish Patel

Lead Sponsor