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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04315090
• Other study ID #: 19-006598
• Status: Withdrawn
• Start date: October 9, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Myelopathy
• Degenerative Spinal Arthritis
• Spinal Cord Diseases
• Spinal Stenosis
• Spondylarthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of readmission		Within 3 months of discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials