Complex Spine Enhanced Recovery After Surgery (ERAS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Scoliosis Idiopathic

Intervention / Treatment
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* Other: Enhanced Recovery After Surgery Protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard post op complex spine orders placed for patients undergoing deformity correction | |
| Experimental: ERAS<br>Enhanced recovery after surgery protocol is applied to the patients undergoing deformity correction | Other: Enhanced Recovery After Surgery Protocol<br>* 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.<br>* Other names: Preoperative analgesia;|

What is the study measuring?
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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 |