Enhanced Recovery After Surgery Protocol for Scoliosis Idiopathic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Scoliosis Idiopathic+1 More
Enhanced Recovery After Surgery Protocol - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a new protocol for spine surgery may help individuals with spinal deformity.

Eligible Conditions
  • Scoliosis Idiopathic

Treatment Effectiveness

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: Preop to post op comparison of ODI at 4 days, 2 weeks, 6 weeks, 12 weeks and 6 months.

Month 12
Narcotic usage
Day 10
Length of Stay
Day 30
30 Day Readmission
30 Day Reoperations
Day 90
90 Day Readmissions
Month 1
Time to mobilization
Week 2
Time to oral intake
Month 6
Change in Oswestry Disability Index Score from Pre-op baseline.
Month 6
Promis Score - Pain
Promis Score - Physical Activity
Promis Score - Physical Function
Month 6
Change in Coronal Cobb Angle
Change in Coronal Imbalance Measurement
Change in Degrees of Apical Vertebra Rotation
Change in Lumbar Lordosis (LL)
Change in Pelvic Incidence (PI)
Change in Pelvic Tilt (PT)
Change in Sacral Slope (SS)
Change in Sagittal Vertical Axis (SVA) Measurement
Change in Thoracic Kyphosis (TK)

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
ERAS
1 of 2

Active Control

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Enhanced Recovery After Surgery Protocol · No Placebo Group · N/A

ERAS
Other
Experimental Group · 1 Intervention: Enhanced Recovery After Surgery Protocol · Intervention Types: Other
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: preop to post op comparison of odi at 4 days, 2 weeks, 6 weeks, 12 weeks and 6 months.

Who is running the clinical trial?

North Carolina Spine SocietyUNKNOWN
University of North Carolina, Chapel HillLead Sponsor
1,362 Previous Clinical Trials
3,927,624 Total Patients Enrolled
1 Trials studying Scoliosis Idiopathic
23 Patients Enrolled for Scoliosis Idiopathic
Andrew Abumoussa, MD MScPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People with scoliosis, as categorized by the International Statistical Classification of Diseases and Related Health Problems (ICD-10), may have a number of health challenges.
, 22856, 22857, 22860, 22861, 22863, 22864, 22865, 22868, 22869, 22903, 22913, 22920, 22921, 22922, 22923, 22924, 22925, 22926, 22927, 22928, 22929, 22930, 22931, those with a diagnosis of spinal tumor will have a global surgical package (GSP) billed instead of the individual CPT codes
A Cobb angle of more than 10 degrees is often associated with a severe spinal curve.
"The patient failed three months of conservative management and required surgery.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New York100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%