Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2020-09-14
2023-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Standard post op complex spine orders placed for patients undergoing deformity correction
No interventions assigned to this group
ERAS
Enhanced recovery after surgery protocol is applied to the patients undergoing deformity correction
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Deformity correction due to trauma
* History of neoplastic spine disease
* Patients with active osteomyelitis
* Patients with prior cement augmentation.
18 Years
ALL
No
Sponsors
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North Carolina Spine Society
UNKNOWN
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Andrew Abumoussa, MD MSc
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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UNC Chapel Hill Hospital
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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20-1705
Identifier Type: -
Identifier Source: org_study_id
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