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

NCT07242989 | Completed

• 1 other identifier: TMW-2025-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Observational study regarding outcomes, complications, and patient acceptance for 100 consecutive patients undergoing outpatient posterior cervical decompression, instrumentation and fusion.

Conditions

Cervical Stenosis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Number of Participants With Postoperative Complications or Readmissions

  Day of surgery through study completion (average 5 years)

• Number of Participants With Radiographic Evidence of Fusion or Hardware Failure

  6 weeks, 3 months, and extended follow-up (average 5 years)

Study Arms (1)

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

Interventions

Enhanced recovery after surgery protocol OTHER

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.

Posterior Cervical Decompression, Instrumentation and Fusion Patients

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NeuroSpine Center of Wisconsin: lead

Study Sites (1)

NeuroSpine Center of Wisconsin

Neenah, Wisconsin, 54956, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: November 21, 2025
• Study Start: December 10, 2019
• Primary Completion: November 20, 2024
• Study Completion: February 28, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)