Adolescent Idiopathic Scoliosis Clinical Trial
Official title:
A Randomized Trial of Postoperative Steroid Use Following Posterior Spinal Fusion in 100-subject Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis (NMS)
The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion. The main question it aims to answer are: - What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)? - Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation? Participants will: - Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years - Have clinical photos of their incision at 3 months, 1 year, and 2 years - Their photos will be assessed using the stony book scar evaluation scale - For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand. - Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2025 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 18 Years |
Eligibility | Inclusion Criteria: Participants must meet all of the inclusion criteria to participate in this study: • Patients aged 9-18 years who are scheduled to undergo posterior spinal fusion to treat AIS or NMS Exclusion Criteria: Patients will be excluded if any of the following criteria are met at baseline: - Prior instrumentation or spine surgery - Conditions associated with increased wound healing issues such as spina bifida - Non AIS or NMS patients - Not undergoing PSF - Outside the ages of 9-18 - Allergies to the steroids and/or their ingredients - Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements - Inability or unwillingness of individual or legal guardian/representative to give written informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles |
United States,
Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7. — View Citation
Chan P, Skaggs DL, Sanders AE, Villamor GA, Choi PD, Tolo VT, Andras LM. Pain is the Greatest Preoperative Concern for Patients and Parents Before Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1245-E1250. doi: 10.1097/BRS.0000000000002147. — View Citation
Fletcher ND, Ruska T, Austin TM, Guisse NF, Murphy JS, Bruce RW Jr. Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. J Bone Joint Surg Am. 2020 Oct 21;102(20):1807-1813. doi: 10.2106/JBJS.20.00259. — View Citation
Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014 May;8(3):257-63. doi: 10.1007/s11832-0 — View Citation
Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain Outcomes in a US Children's Hospital: A Prospective Cross-Sectional Survey. Hosp Pediatr. 2015 Jan;5(1):18-26. doi: 10.1542/hpeds.2014-0084. — View Citation
Gonzalez L. Pediatric Opioid Prescribing: A Call for Calm. Pediatrics. 2021 Sep;148(3):e2021052190. doi: 10.1542/peds.2021-052190. Epub 2021 Aug 16. No abstract available. — View Citation
Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16. — View Citation
Keohane D, Sheridan G, Harty J. Perioperative steroid administration improves knee function and reduces opioid consumption in bilateral total knee arthroplasty. J Orthop. 2020 Oct 7;22:449-453. doi: 10.1016/j.jor.2020.10.004. eCollection 2020 Nov-Dec. — View Citation
Singla A, Qureshi R, Chen DQ, Nourbakhsh A, Hassanzadeh H, Shimer AL, Shen FH. Risk of Surgical Site Infection and Mortality Following Lumbar Fusion Surgery in Patients With Chronic Steroid Usage and Chronic Methicillin-Resistant Staphylococcus aureus Infection. Spine (Phila Pa 1976). 2019 Apr 1;44(7):E408-E413. doi: 10.1097/BRS.0000000000002864. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of Stay | Day/hours to discharge from hospital following completion of surgery. | From date of hospitalization for surgery until date of first discharge, assessed up to two weeks | |
Primary | Post Operative Opioid Use | Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg) | From date of hospitalization for surgery until date of first discharge, assessed up to two weeks | |
Secondary | Post Operative Ambulation (for ambulatory patients) | Will obtain number of feet ambulated with physical therapy (PT) staff on each post operative day. Will record number of days postoperatively until PT clearance for discharge. | From date of hospitalization for surgery until date of first discharge, assessed up to two weeks | |
Secondary | Return of Bowel Function | Will record time to return of bowel sounds as noted by nursing or house staff. Will record time to first bowel movement. | From date of hospitalization for surgery until date of first discharge, assessed up to two weeks | |
Secondary | Rate of wound complications requiring intervention | 3.1) Additional clinic visits for drainage or wound concerns will be recorded. 3.2) Use of antibiotic for superficial wound issues will be recorded. 3.3) Any additional operative intervention or hospitalization for concern/management of an infection. | Less than 90 days from hospitalization | |
Secondary | Scar Appearance | Clinical photos will be obtained and graded with Stony Brook Scar Evaluation Scale.
The Stony Brook Scar evaluation scale ranges from a minimum value of 0 (worst) to a maximum value of 5 (best). |
Immediately from enrollment through study completion, at an average of 2 years | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) | The Patient-Reported Outcomes Measurement Information System is a validated quality of life and outcome questionnaire used for various studies. This will also be completed by the parent, if the patient is unable to do so.
PROMIS domains that will be utilized include: pain interference A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used. A higher score is indicative of more problems with pain hindering activities than a lower score. physical activity A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used. A higher score is indicative of engagement with more physical activities than a lower score. mobility A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used. A higher score is indicative of engagement with more mobility than a lower score. |
Immediately from enrollment through study completion, at an average of 2 years | |
Secondary | Post-Operative Complications | Any additional emergency room visits/readmission or revision surgery | Within 2 years from date of surgery. | |
Secondary | Body Mass Index | Weight, measured in kilograms, and height, measured in meters, will be combined to report body mass index in kg/m^2 | Immediately from enrollment through study completion, at an average of 2 years |
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