Complex Spine Enhanced Recovery After Surgery (ERAS)

Scoliosis Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04538092
• Other study ID #: 20-1705
• Status: Terminated
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: October 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic

Intervention

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.

Locations

Country	Name	City	State
United States	UNC Chapel Hill Hospital	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Spine Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Narcotic usage	Total morphine milligram equivalents (MME) utilized while inpatient and after discharge	From conclusion of surgery to 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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