NCT04538092

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 18, 2023

Status Verified

October 1, 2022

Enrollment Period

3.1 years

First QC Date

August 20, 2020

Last Update Submit

November 14, 2023

Conditions

Scoliosis Idiopathic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Narcotic usage

    From conclusion of surgery to 12 months

  • 30 Day Readmission

    From day of hospital discharge to 30 days

  • 90 Day Readmissions

    From day of hospital discharge to 90 days

  • 30 Day Reoperations

    From day of hospital discharge to 30 days

  • Change in Oswestry Disability Index Score from Pre-op baseline.

    Preop to post op comparison of ODI at 4 days, 2 weeks, 6 weeks, 12 weeks and 6 months.

  • +14 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Standard post op complex spine orders placed for patients undergoing deformity correction

ERAS

EXPERIMENTAL

Enhanced recovery after surgery protocol is applied to the patients undergoing deformity correction

Other: Enhanced Recovery After Surgery Protocol

Interventions

Enhanced Recovery After Surgery ProtocolOTHER

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.

Also known as: Preoperative education, Preoperative nutrition, Intraoperative analgesia, Intraoperative fluid resuscitation, Postoperative analgesic, Postoperative mobilization, Postoperative nutrition, Preoperative screening, Postoperative antibiotics, Preoperative analgesia
ERAS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Study Officials

  • Andrew Abumoussa, MD MSc

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2020

First Posted

September 3, 2020

Study Start

September 14, 2020

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 18, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Deidentified individual data that supports the results will be shared beginning 36 months following publication
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.

Locations

US(1)