Cervical Stenosis
Conditions
Brief summary
Observational study regarding outcomes, complications, and patient acceptance for 100 consecutive patients undergoing outpatient posterior cervical decompression, instrumentation and fusion.
Interventions
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.
Sponsors
NeuroSpine Center of Wisconsin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myelopathy Severity (Nurick Grade) | Baseline and 3 months post-operative | Myelopathy severity will be measured using the Nurick Scale (Grades 0-5), with higher grades indicating greater impairment. |
| Functional Disability (Oswestry Neck Pain Index) | Baseline and 3 months post-operative | Functional impairment will be assessed using the Oswestry Neck Pain Index (0-100%). |
| Surgical Outcome Rating (Odom Criteria) | 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). |
| Neurologic Function (Modified JOA Score) | 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. |
| Pain Severity (VAS Neck and Arm Pain Scores) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Radiographic Evidence of Fusion or Hardware Failure | 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. |
| Number of Participants With Postoperative Complications or Readmissions | 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. |
Countries
United States
Outcome results
None listed