Immune Response to PSF in Idiopathic vs Neuromuscular Scoliosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-99
SponsorAmbrish Patel
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any patient undergoing a posterior spinal fusion, regardless of age (birth to adult)
any patient with a diagnosis of idiopathic or neuromuscular scoliosis
Disqualifiers
Patient taking immunomodulators (monoclonal antibodies, chemotherapeutic agents)
chronic steroid use
Trial population
Idiopathic or neuromuscular scoliosis undergoing posterior spinal fusion
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Serum blood samples for serum biomarkers of immune response
Diagnostic testPreoperative and postoperative blood samples using biomarkers to evaluate immune response.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Neuromuscular scoliosis1 intervention
Group B: Idiopathic scoliosis1 intervention
Trial outcomes
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.
Time frame
From enrollment to approximately one hour after surgery completion.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ambrish Patel
Lead sponsor
Nationwide Children's Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: