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Completed

NCT Number: NCT07242989

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

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

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Key information

Conditions

Cervical Stenosis

Sex eligibility

All sexes

Study type

Observational

Primary location

NeuroSpine Center of Wisconsin

Neenah, Wisconsin, 54956, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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%).

  5. 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).

Secondary outcomes

  1. Number of Participants With Postoperative Complications or Readmissions

    Time frame: Day of surgery through study completion (average 5 years)

    All postoperative medical and surgical complications-including ER visits, unplanned admissions, and reoperations-will be recorded.

  2. Number of Participants With Radiographic Evidence of Fusion or Hardware Failure

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

    Radiographic evaluation of fusion status, hardware failure, and pseudoarthrosis will be performed using AP/lateral and flexion-extension cervical spine radiographs.

Sponsors and collaborators

Lead sponsor

NeuroSpine Center of Wisconsin

Other

Registry information

Official study title

Outpatient Posterior Cervical Decompression, Instrumentation, and Fusion: The First Consecutive 100 Cases

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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