Cervical StenosisNCT07242989
Outpatient Posterior Cervical Fusion: Outcomes of the First 100 Consecutive Cases
An observational study of Cervical Stenosis, run by NeuroSpine Center of Wisconsin at 1 site in United States.
Trial summary
Observational study regarding outcomes, complications, and patient acceptance for 100 consecutive patients undergoing outpatient posterior cervical decompression, instrumentation and fusion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Stenosis
- What is being tested?
- Enhanced recovery after surgery protocol
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 28 Feb 2025
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Adult males and females referred to the NeuroSpine Center of Wisconsin in Appleton, WI, with cervical stenosis.
Who may be able to join
- patients with neurological signs and symptoms related to cervical stenosis, confirmed by MRI, who have failed to improve with appropriate conservative management.
Who cannot join
- patients who represent an inordinate risk to undergo general anesthesia in the outpatient setting.
Trial locations and contacts
1 site in 1 country.
United States1 site
NeuroSpine Center of Wisconsin
Neenah, Wisconsin, 54956
About this study
Official title: Outpatient Posterior Cervical Decompression, Instrumentation, and Fusion: The First Consecutive 100 Cases
Observational study regarding outcomes, complications, and patient acceptance for 100 consecutive patients undergoing outpatient posterior cervical decompression, instrumentation and fusion.
- Conditions
- Cervical Stenosis
- Being tested
- Enhanced recovery after surgery protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surgery protocolOther
This is the only study evaluating OUTPATIENT posterior cervical decompression, instrumentation, and fusion patients in a prospective fashion with a median follow-up of 2.5 years.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Cervical Decompression, Instrumentation and Fusion Patients | 100 consecutive patients with documented cervical spinal cord and/or nerve root compression unresponsive to conservative management. Receives: Other: Enhanced recovery after surgery protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic Function (Modified JOA Score)
Neurologic status will be assessed using the Modified Japanese Orthopaedic Association (mJOA) Score (1-18), with higher scores indicating better neurologic function.
Measured: Baseline and 3 months post-operative
Myelopathy Severity (Nurick Grade)
Myelopathy severity will be measured using the Nurick Scale (Grades 0-5), with higher grades indicating greater impairment.
Measured: Baseline and 3 months post-operative
Pain Severity (VAS Neck and Arm Pain Scores)
Pain will be assessed using the Visual Analog Scale (VAS) for neck and arm pain (0-10).
Measured: Baseline, 3 months post-operative, and final follow-up (average 5 years)
Functional Disability (Oswestry Neck Pain Index)
Functional impairment will be assessed using the Oswestry Neck Pain Index (0-100%).
Measured: Baseline and 3 months post-operative
Surgical Outcome Rating (Odom Criteria)
Patient-reported surgical outcome will be graded using Odom Criteria (Excellent, Good, Fair, Poor).
Measured: 3 months post-operative and extended follow-up (average 5 years)
Secondary outcomes (2)
Number of Participants With Postoperative Complications or Readmissions
All postoperative medical and surgical complications-including ER visits, unplanned admissions, and reoperations-will be recorded.
Measured: Day of surgery through study completion (average 5 years)
Number of Participants With Radiographic Evidence of Fusion or Hardware Failure
Radiographic evaluation of fusion status, hardware failure, and pseudoarthrosis will be performed using AP/lateral and flexion-extension cervical spine radiographs.
Measured: 6 weeks, 3 months, and extended follow-up (average 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start10 Dec 2019
- Primary completion20 Nov 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical StenosisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroSpine Center of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242989
- Sponsor's protocol ID
- TMW-2025-001
- Status last verified
- Nov 2025
- First submitted
- 24 Oct 2025
- Last updated
- 21 Nov 2025
- Results posted
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Posterior Cervical Decompression, Instrumentation, and Fusion: The First Consecutive 100 Cases
- ClinicalTrials.gov ID
- NCT07242989
- Acronym / sponsor ID
- TMW-2025-001
- Conditions
- Cervical Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NeuroSpine Center of WisconsinUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 21 Nov 2025 (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.
Observational study regarding outcomes, complications, and patient acceptance for 100 consecutive patients undergoing outpatient posterior cervical decompression, instrumentation and fusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posterior Cervical Decompression, Instrumentation and Fusion Patients | – | Other: Enhanced recovery after surgery protocol100 consecutive patients with documented cervical spinal cord and/or nerve root compression unresponsive to conservative management. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adult males and females referred to the NeuroSpine Center of Wisconsin in Appleton, WI, with cervical stenosis.
Key inclusion criteria (1 listed)
- patients with neurological signs and symptoms related to cervical stenosis, confirmed by MRI, who have failed to improve with appropriate conservative management.
Key exclusion criteria (1 listed)
- patients who represent an inordinate risk to undergo general anesthesia in the outpatient setting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery after surgery protocolThis is the only study evaluating OUTPATIENT posterior cervical decompression, instrumentation, and fusion patients in a prospective fashion with a median follow-up of 2.5 years. | Other | Posterior Cervical Decompression, Instrumentation and Fusion Patients |
Primary outcome
Neurologic Function (Modified JOA Score)
Time frame: Baseline and 3 months post-operative
Neurologic status will be assessed using the Modified Japanese Orthopaedic Association (mJOA) Score (1-18), with higher scores indicating better neurologic function.
Myelopathy Severity (Nurick Grade)
Time frame: Baseline and 3 months post-operative
Myelopathy severity will be measured using the Nurick Scale (Grades 0-5), with higher grades indicating greater impairment.
Pain Severity (VAS Neck and Arm Pain Scores)
Time frame: Baseline, 3 months post-operative, and final follow-up (average 5 years)
Pain will be assessed using the Visual Analog Scale (VAS) for neck and arm pain (0-10).
Functional Disability (Oswestry Neck Pain Index)
Time frame: Baseline and 3 months post-operative
Functional impairment will be assessed using the Oswestry Neck Pain Index (0-100%).
Surgical Outcome Rating (Odom Criteria)
Time frame: 3 months post-operative and extended follow-up (average 5 years)
Patient-reported surgical outcome will be graded using Odom Criteria (Excellent, Good, Fair, Poor).
2 secondary outcomes
Number of Participants With Postoperative Complications or Readmissions
Time frame: Day of surgery through study completion (average 5 years)
Number of Participants With Radiographic Evidence of Fusion or Hardware Failure
Time frame: 6 weeks, 3 months, and extended follow-up (average 5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Cervical Stenosis
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Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
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Assessing Microbiome in Primary Anterior Cervical Fusion Patients
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Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
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Hard Cervical Collar Use Following Posterior Cervical Fusion
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Stenosis, run by NeuroSpine Center of Wisconsin at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neurologic Function (Modified JOA Score) (time frame: Baseline and 3 months post-operative). The study lists 5 primary outcomes in all. 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 21 Nov 2025.