RecruitingNot ApplicableNCT03023696

Can Prophylactic Foraminotomy Prevent C5 Palsy

A Randomized, Prospective Study Determining the Impact of Prophylactic Bilateral Foraminotomy During Cervical Decompression on C5 Palsy


Sponsor

The Cleveland Clinic

Enrollment

480 participants

Start Date

Jun 1, 2016

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study at the Cleveland Clinic investigates whether performing a preventive foraminotomy (a small bone-widening procedure) during posterior cervical spine surgery can prevent C5 palsy — a complication that causes shoulder and arm weakness after neck surgery. Patients with cervical myelopathy (spinal cord compression in the neck) are enrolled. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with cervical myelopathy (spinal cord compression in the neck) without radiculopathy (nerve root pain) - You are scheduled for posterior cervical decompression surgery involving the C4-C5 level (laminoplasty or laminectomy with fusion) You may NOT be eligible if: - You are under 18 years of age - You have pre-existing C5 radiculopathy (deltoid muscle weakness of Grade 3 or less) - You have had previous cervical spine surgery - You have a spinal tumor, trauma, or infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBilateral Cervical Keyhole Foraminotomy

Under microscopic or loop magnification, a high-speed burr is used to perform the foraminotomy. The keyhole foraminotomy begins at the lamina-facet junction, with careful consideration of the amount of facet resection. Typically, only the medial one third is drilled. Then a 1- or 2-mm Kerrison punch can be carefully placed over the nerve root and then used to undercut the facet, ensuring that the spine is not destabilized by the foraminotomy. The amount of facet resection must not exceed 50% in order to preserve spine stability.

PROCEDURECervical Decompression

Cervical decompression for myelopathy, including the following procedures: laminoplasty, laminectomy, discectomy and fusion


Locations(1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

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NCT03023696


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