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

Withdrawn

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

• Registration Number: NCT04315090
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-19
• Study Start: 2020-10-09
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-10
• Primary Completion: 2022-05-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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