Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion

This research study is being conducted to help improve the pre-operative, intra-operative, and post-operative course for patients and enhance recovery.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Stenosis; Cervical Myelopathy; Degenerative Spinal Arthritis

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults scheduled to undergo posterior cervical spinal fusion.

Description

Inclusion Criteria:

• Age 18 to 89
• Diagnosis of cervical myelopathy, cervical stenosis, cervical disc disorder, or cervical spondylolisthesis

Exclusion Criteria:

• Cervical injury as the indication for surgery
• Emergent surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	We will record the length of stay (date of admission to date of discharge) for the operative admission at the time of discharge.	Will record length of stay in days 3 months following admission date.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of readmission		Within 3 months of discharge
Numerical rating scale (NRS)- pain	Numerical score of neck pain. Scored 0 to 10. 10 is the worst pain.	immediately before, immediately after, and 3 months after surgery
SF-12 short form	SF-12 short form health survey. Scored 0 to 100. 100 is the highest level of health.	immediately before, immediately after, and 3 months after surgery
Oswestry Disability Index	questionnaire regarding low back pain. Scored 0 to 100. 100 being most severe disability.	immediately before, immediately after, and 3 months after surgery
Number of sessions with physical therapy and occupational therapy	record of number of sessions completed with physical or occupational therapy during the operative admission. We will determine this number at the time of discharge. We will calculate this number only once.	will record number of physical and occupational therapy sessions during surgical admission 3 months following admission date
Disposition status	We will determine the disposition status at the time of discharge following the operative admission. We will do this only once.	will record discharge disposition 3 months following surgical admission date

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Matthew Neal, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 9, 2020
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (ACTUAL): March 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylitis; Spinal Cord Diseases; Spinal Stenosis; Spondylarthritis
• Other Study ID Numbers: 19-006598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No