Complex Spine Enhanced Recovery After Surgery (ERAS)

Single Institution Prospective Analysis of an Enhanced Recovery After Complex Spine Surgery Protocol

In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.

Study Overview

• Status: Terminated
• Conditions: Scoliosis Idiopathic
• Intervention / Treatment: Other: Enhanced Recovery After Surgery Protocol

Detailed Description

Purpose : In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.

Participants : Patients undergoing surgery aimed at treating adult spinal deformity are the subject of this research. This population was chosen as these procedures are often associated with prolonged length of stay (LOS), high post-operative narcotic use, and often require complex post-operative discharge planning.

Procedures : Patients undergoing surgery to address the complications of ASD present a unique challenge in that this patient population is diverse, and there are multiple operative procedures available to treat the same condition. Given that there are currently no accepted or recommended Enhanced Recovery After Surgery protocols for complex spine procedures, the investigators have developed an ERAS protocol at the University of North Carolina (UNC) in collaboration with the anesthesia department for the support of complex surgical patients.

Hypothesis: Implementing a multi-modal enhanced recovery after complex spine surgery protocol will improve patient measured outcomes and patient functional outcomes leading to a statistically significant reduction in LOS, post-operative pain, complication rate, cost.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew L Abumoussa, MD MSc; Phone Number: 984-974-1000; Email: andrew@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Chapel Hill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with a diagnosis of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) Scoliosis (M41.9) category.
• Patients undergoing a > 5 level arthrodesis using one of the following Current Procedural Terminology (CPT) coded procedures 22534, 22585, 22614, 22632, 22634 with either 22842, 22853
• Cobb angle > 10 degrees
• Failure of 3 months of conservative management

Exclusion Criteria:

• Prior scoliosis surgery not performed at UNC Chapel Hill Hospital Facilities
• Deformity correction due to trauma
• History of neoplastic spine disease
• Patients with active osteomyelitis
• Patients with prior cement augmentation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard post op complex spine orders placed for patients undergoing deformity correction
Experimental: ERAS; Enhanced recovery after surgery protocol is applied to the patients undergoing deformity correction	Other: Enhanced Recovery After Surgery Protocol; The investigators have developed an Enhanced Recovery After Surgery protocol for complex spine surgery at UNC. This study will help elucidate the effects of multiple interventions tailored to help patients recover from complex surgery.; Other Names: Preoperative education; Preoperative nutrition; Intraoperative analgesia; Intraoperative fluid resuscitation; Postoperative analgesic; Postoperative mobilization; Postoperative nutrition; Preoperative screening; Postoperative antibiotics; Preoperative analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Number of nights spent in the hospital following surgery	From conclusion of surgery to hospital discharge, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotic usage	Total morphine milligram equivalents (MME) utilized while inpatient and after discharge	From conclusion of surgery to 12 months
30 Day Readmission	Did the patient require a repeat hospitalization within 30 days after the initial surgery?	From day of hospital discharge to 30 days
90 Day Readmissions	Did the patient require a repeat hospitalization within 90 days after the initial surgery	From day of hospital discharge to 90 days
30 Day Reoperations	Did the patient require a repeat reoperation within 30 days after the initial surgery	From day of hospital discharge to 30 days
Change in Oswestry Disability Index Score from Pre-op baseline.	The Oswestry Disability Index (ODI) for functional impairment is used to quantify disability related to lower back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Higher scores reflect more severe disability. The Oswestry Disability Index (ODI) measures patients' degree of disability related to lower back pain. The ODI has 10 items (Pain, self-care, bring, walking, sitting, standing, sleeping, sex, social, and travelling). After adding up the total score of each item, the initial total score is 0 to 50 points. Then divide the total score by 5 and multiply by 20 to get the final score of 0 to 100.	Preop to post op comparison of ODI at 4 days, 2 weeks, 6 weeks, 12 weeks and 6 months.
Promis Score - Pain	Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured.	Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
Promis Score - Physical Activity	Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured.	Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
Promis Score - Physical Function	Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured.	Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
Time to mobilization	The amount of time needed from the completion of surgery until the patient is ambulating out of bed	From the end of surgery until the date of hospital discharge, assessed up to 1 month.
Time to oral intake	The amount of time needed from the completion of surgery until the patient is able to take food or drink orally	From the end of surgery until the date of oral intake, assessed up to 2 weeks.
Change in Coronal Cobb Angle	Standard radiographic description of standing scoliosis x-ray made using the Cobb angle measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months	Within 6 months pre-operatively and up to 6 months postoperatively
Change in Degrees of Apical Vertebra Rotation	Standard radiographic description of the change between standing scoliosis x-ray made using the Apical Vertebra's Rotation measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months	Within 6 months pre-operatively and up to 6 months postoperatively
Change in Thoracic Kyphosis (TK)	Standard radiographic description of standing scoliosis x-ray made using the Thoracic Kyphosis (TK) measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months	Within 6 months pre-operatively and up to 6 months postoperatively
Change in Lumbar Lordosis (LL)	Standard radiographic description of standing scoliosis x-ray made using the Lumbar Lordosis (LL) measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months	Within 6 months pre-operatively and up to 6 months postoperatively
Change in Sacral Slope (SS)	Standard radiographic description of standing scoliosis x-ray made using the Sacral Slope (SS) measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months	Within 6 months pre-operatively and up to 6 months postoperatively
Change in Pelvic Tilt (PT)	Standard radiographic description of standing scoliosis x-ray made using the Pelvic Tilt (PT) measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months	Within 6 months pre-operatively and up to 6 months postoperatively
Change in Pelvic Incidence (PI)	Standard radiographic description of standing scoliosis x-ray made using the Pelvic Incidence (PI) measured in degrees. Assessed pre and post-operatively at 2, 6, and 12 weeks and 6 months	Within 6 months pre-operatively and up to 6 months postoperatively
Change in Sagittal Vertical Axis (SVA) Measurement	Sagittal Vertical Axis (SVA) measurement assessed using standing scoliosis x-ray and reported in centimeters	Within 6 months pre-operatively and up to 6 months postoperatively
Change in Coronal Imbalance Measurement	Coronal Imbalance measurement assessed using standing scoliosis x-ray and reported in centimeters	Within 6 months pre-operatively and up to 6 months postoperatively

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Spine Society
• Investigators: Principal Investigator: Andrew Abumoussa, MD MSc, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Sensory System Agents; Anti-Bacterial Agents; Analgesics
• Other Study ID Numbers: 20-1705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: Deidentified individual data that supports the results will be shared beginning 36 months following publication
• IPD Sharing Access Criteria: An investigator who proposes to use the data must have approval from an IRB, IEC, or REB, as applicable and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No