Clinical trial NCT04538092: Complex Spine Enhanced Recovery After Surgery (ERAS)
Official title: Single Institution Prospective Analysis of an Enhanced Recovery After Complex Spine Surgery Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Scoliosis Idiopathic
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Spine Society
First posted: 2020-09-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of Stay
timeFrame: From conclusion of surgery to hospital discharge, an expected average of 10 days
Secondary outcomes:
measure: Narcotic usage
timeFrame: From conclusion of surgery to 12 months
measure: 30 Day Readmission
timeFrame: From day of hospital discharge to 30 days
measure: 90 Day Readmissions
timeFrame: From day of hospital discharge to 90 days
measure: 30 Day Reoperations
timeFrame: From day of hospital discharge to 30 days
measure: Change in Oswestry Disability Index Score from Pre-op baseline.
timeFrame: Preop to post op comparison of ODI at 4 days, 2 weeks, 6 weeks, 12 weeks and 6 months.
measure: Promis Score - Pain
timeFrame: Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
measure: Promis Score - Physical Activity
timeFrame: Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
measure: Promis Score - Physical Function
timeFrame: Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.
measure: Time to mobilization
timeFrame: From the end of surgery until the date of hospital discharge, assessed up to 1 month.
measure: Time to oral intake
timeFrame: From the end of surgery until the date of oral intake, assessed up to 2 weeks.
measure: Change in Coronal Cobb Angle
timeFrame: Within 6 months pre-operatively and up to 6 months postoperatively
measure: Change in Degrees of Apical Vertebra Rotation
timeFrame: Within 6 months pre-operatively and up to 6 months postoperatively
measure: Change in Thoracic Kyphosis (TK)
timeFrame: Within 6 months pre-operatively and up to 6 months postoperatively
measure: Change in Lumbar Lordosis (LL)
timeFrame: Within 6 months pre-operatively and up to 6 months postoperatively
measure: Change in Sacral Slope (SS)
timeFrame: Within 6 months pre-operatively and up to 6 months postoperatively
measure: Change in Pelvic Tilt (PT)
timeFrame: Within 6 months pre-operatively and up to 6 months postoperatively
measure: Change in Pelvic Incidence (PI)
timeFrame: Within 6 months pre-operatively and up to 6 months postoperatively
measure: Change in Sagittal Vertical Axis (SVA) Measurement
timeFrame: Within 6 months pre-operatively and up to 6 months postoperatively
measure: Change in Coronal Imbalance Measurement
timeFrame: Within 6 months pre-operatively and up to 6 months postoperatively
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Andrew Abumoussa, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: