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NCT03023696 · ClinicalTrials.gov registry record · NA
Can Prophylactic Foraminotomy Prevent C5 Palsy
A NA study of Myelopathy, Compressive and Radiculopathy, Cervical, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 480
- Enrollment target
- 1
- Study location
NCT03023696 is a NA study of Myelopathy, Compressive and Radiculopathy, Cervical that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 480 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03023696, a NA study of Myelopathy, Compressive and Radiculopathy, Cervical, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 480 participants
- Enrollment target
- 1
- Study location
Study Summary
C5 palsy (C5P) is a well-known, although rare complication of cervical spine decompression surgery. In severe forms, C5P causes debilitating upper extremity weakness involving the deltoids and/or biceps brachii muscles, ultimately diminishing these patients' quality of life. Furthermore, about half of patients with C5P present with sensory deficits and/or intractable pain in addition to the muscle weakness. Prophylactic bilateral foraminotomy at the C5 level during cervical decompression surgery has been studied recently with the hope that it will minimize the risk of developing a C5 nerve root palsy postoperatively. Although the current literature provides some support for this claim, there are insufficient data establishing this technique as a proven measure to reduce the incidence of C5P. In the present study, we seek to evaluate the effect of bilateral foraminotomy on postoperative C5P incidence rates. Bilateral foraminotomy has been correlated with a reduced risk of developing C5P following cervical decompression surgery, but an identical foraminotomy procedure has never been applied in a randomized manner to all qualifying patients in a study. Additionally, prophylactic foraminotomy has only been prospectively studied during laminoplasty. In the proposed study, bilateral foraminotomy will be randomized to patients receiving cervical decompression surgery (laminoplasty, laminectomy, fusion). This is a multicenter randomized trial, including the following sites: Cleveland Clinic, Columbia University Medical Center, and University of Southern California Spine Center. Patients undergoing cervical decompression surgery will be consented and enrolled if they meet the inclusion and exclusion criteria. Subsequently, incidence of C5P will be monitored to determine efficacy of prophylactic C5 bilateral foraminotomy during cervical decompression.
Conditions Studied
Interventions
- PROCEDURE Bilateral Cervical Keyhole Foraminotomy
- PROCEDURE Cervical Decompression
Study Locations (1)
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2016-06 |
| Est. Completion | 2026-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03023696
The ClinicalTrials.gov registry entry for NCT03023696 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Myelopathy, Compressive appearing as the primary indexed condition, and to 2 interventions - of which Bilateral Cervical Keyhole Foraminotomy is the first listed.
NCT03023696 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03023696 about?
NCT03023696 is a clinical study titled "Can Prophylactic Foraminotomy Prevent C5 Palsy". C5 palsy (C5P) is a well-known, although rare complication of cervical spine decompression surgery. In severe forms, C5P causes debilitating upper extremity weakness involving the deltoids and/or biceps brachii muscles, ultimately diminishing these patients' quality of life. Furthermore, about half ...
What is the current status of trial NCT03023696?
This trial is currently recruiting. It is a NA study. The enrollment target is 480 participants. The study started on 2016-06. Estimated completion is 2026-12.
What conditions does trial NCT03023696 study?
This clinical trial studies the following conditions: Myelopathy, Compressive, Radiculopathy, Cervical, C5 Palsy.
What interventions are being tested in trial NCT03023696?
The interventions under investigation include: Bilateral Cervical Keyhole Foraminotomy (PROCEDURE), Cervical Decompression (PROCEDURE).
Who is sponsoring clinical trial NCT03023696?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03023696 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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