Outpatient Posterior Cervical Fusion: Outcomes of the First 100 Consecutive Cases

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.

Study Overview

• Status: Completed
• Conditions: Cervical Stenosis
• Intervention / Treatment: Other: Enhanced recovery after surgery protocol

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Neenah, Wisconsin, United States, 54956
      • NeuroSpine Center of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult males and females referred to the NeuroSpine Center of Wisconsin in Appleton, WI, with cervical stenosis.

Description

Inclusion Criteria:

• patients with neurological signs and symptoms related to cervical stenosis, confirmed by MRI, who have failed to improve with appropriate conservative management.

Exclusion Criteria:

• patients who represent an inordinate risk to undergo general anesthesia in the outpatient setting.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Posterior Cervical Decompression, Instrumentation and Fusion Patients; 100 consecutive patients with documented cervical spinal cord and/or nerve root compression unresponsive to conservative management.	Other: Enhanced recovery after surgery protocol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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%).	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).	3 months post-operative and extended follow-up (average 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Postoperative Complications or Readmissions	All postoperative medical and surgical complications-including ER visits, unplanned admissions, and reoperations-will be recorded.	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.	6 weeks, 3 months, and extended follow-up (average 5 years)

Collaborators and Investigators

• Sponsor: NeuroSpine Center of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): November 20, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: October 24, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: TMW-2025-001

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