Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Recruiting NA study of Myelopathy, Compressive and Radiculopathy, Cervical, sponsored by The Cleveland Clinic.

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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

Using manual muscle testing and upper extremity sensory exam findings to determine C5 palsy status. C5P is defined as: a reduction of at least 1 in deltoid and/or biceps brachii manual muscle testing scores compared to preoperative scores, without any deterioration of myelopathic symptoms.

Interventions

  • PROCEDURE Bilateral Cervical Keyhole Foraminotomy
  • PROCEDURE Cervical Decompression

Study Locations (1)

Ohio

  • Cleveland Clinic Foundation - Cleveland

Trial Details

FieldValue
Enrollment Target 480 participants
Start Date 2016-06
Est. Completion 2026-12
Phase NA
The Cleveland Clinic

688 total trials

What NCT03023696 shows while recruiting

NCT03023696 is an interventional study that assigns participants to a tested intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower).

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 a single indexed study location in 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.

How this trial's enrollment target compares

Where NCT03023696's enrollment target sits among peer trials

480 216th of 2000 higher than 1,783 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01954992 · 480 participants · Phase 3

    Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

  • NCT04948060 · 480 participants · NA

    Tribally Engaged Approaches to Lung Screening (TEALS)

  • NCT05053230 · 480 participants · NA

    A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer

  • NCT05279300 · 480 participants · Phase 1

    A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT03023696, the US trial registry maintained by the National Library of Medicine. NCT03023696 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.