Degenerative Spinal ArthritisNCT04315090
Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
An observational study of Degenerative Spinal Arthritis and Cervical Myelopathy, run by Mayo Clinic.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Degenerative Spinal Arthritis, Cervical Myelopathy, Spinal Stenosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults scheduled to undergo posterior cervical spinal fusion.
Who may be able to join
- Age 18 to 89
- Diagnosis of cervical myelopathy, cervical stenosis, cervical disc disorder, or cervical spondylolisthesis
Who cannot join
- Cervical injury as the indication for surgery
- Emergent surgery
About this study
This research study is being conducted to help improve the pre-operative, intra-operative, and post-operative course for patients and enhance recovery.
- Medical subject headings
- Spinal Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Will record length of stay in days 3 months following admission date.
Secondary outcomes (6)
Rate of readmission
Measured: Within 3 months of discharge
Numerical rating scale (NRS)- pain
Numerical score of neck pain. Scored 0 to 10. 10 is the worst pain.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: will record discharge disposition 3 months following surgical admission date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start9 Oct 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: Personnel change and inadequate resources to proceed with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Spinal ArthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew T. Neal, Mayo Clinic
- Investigators
- Matthew Neal, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315090
- Sponsor's protocol ID
- 19-006598
- Status last verified
- Nov 2021
- First submitted
- 18 Mar 2020
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
- ClinicalTrials.gov ID
- NCT04315090
- Acronym / sponsor ID
- 19-006598
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Personnel change and inadequate resources to proceed with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Oct 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being conducted to help improve the pre-operative, intra-operative, and post-operative course for patients and enhance recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults scheduled to undergo posterior cervical spinal fusion.
Key inclusion criteria (2 listed)
- Age 18 to 89
- Diagnosis of cervical myelopathy, cervical stenosis, cervical disc disorder, or cervical spondylolisthesis
Key exclusion criteria (2 listed)
- Cervical injury as the indication for surgery
- Emergent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of stay
Time frame: 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.
6 secondary outcomes
Rate of readmission
Time frame: Within 3 months of discharge
Numerical rating scale (NRS)- pain
Time frame: immediately before, immediately after, and 3 months after surgery
SF-12 short form
Time frame: immediately before, immediately after, and 3 months after surgery
Oswestry Disability Index
Time frame: immediately before, immediately after, and 3 months after surgery
Number of sessions with physical therapy and occupational therapy
Time frame: will record number of physical and occupational therapy sessions during surgical admission 3 months following admission date
Disposition status
Time frame: will record discharge disposition 3 months following surgical admission date
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Neal, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Spinal Arthritis and Cervical Myelopathy, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: Will record length of stay in days 3 months following admission date.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021; AzTrials last refreshed its copy on 27 Oct 2026.