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Can Prophylactic Foraminotomy Prevent C5 Palsy

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ClinicalTrials.gov Identifier: NCT03023696
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : January 5, 2023
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Thomas Mroz, MD, The Cleveland Clinic

Brief 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.


Condition or disease Intervention/treatment Phase
Myelopathy, Compressive Radiculopathy, Cervical C5 Palsy Procedure: Bilateral Cervical Keyhole Foraminotomy Procedure: Cervical Decompression Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective Study Determining the Impact of Prophylactic Bilateral Foraminotomy During Cervical Decompression on C5 Palsy
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arm Intervention/treatment
Experimental: Foraminotomy Group
Prophylactic bilateral cervical keyhole foraminotomy will be done in addition to their decompression surgery
Procedure: Bilateral 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.

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

Active Comparator: Control Group
Cervical decompression will be done without prophylactic bilateral foraminotomy
Procedure: Cervical Decompression
Cervical decompression for myelopathy, including the following procedures: laminoplasty, laminectomy, discectomy and fusion




Primary Outcome Measures :
  1. C5 Palsy [ Time Frame: Upon discharge, 2 weeks postoperatively and 3 months postoperatively ]
    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.


Secondary Outcome Measures :
  1. Preoperative anatomic measurements [ Time Frame: Preoperative ]
    Anteroposterior diameter, foraminal diameter and cord-lamina angle will be determined using preoperative computed tomography scan

  2. Operative time [ Time Frame: Intra-operative measurement ]
    Time length of operation

  3. Blood loss [ Time Frame: Intra-operative measurement ]
    Amount of blood loss during surgery

  4. Back Pain [ Time Frame: Preoperative, 2 weeks postoperative and 3 months postoperative ]
    Visual Analog Scale for Back Pain (0-10)

  5. Leg Pain [ Time Frame: Preoperative, 2 weeks postoperative and 3 months postoperative ]
    Visual Analog Scale for Leg Pain (0-10)

  6. Emergency department visit [ Time Frame: within 90 days postoperatively ]
    Subject has Emergency department visit

  7. Readmission to hospital [ Time Frame: within 90 days postoperatively ]
    Subject is readmitted to hospital within 90 days post-operatively



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cleveland Clinic patients who have been diagnosed with cervical myelopathy, without radiculopathy, and will undergo posterior cervical decompression involving the C4-C5 interspace between 2016 and 2018. This includes patients undergoing cervical laminoplasty and cervical laminectomy and fusion.

Exclusion Criteria:

  • Any patient younger than 18 years of age will not be included on the basis of skeletal immaturity. Patients with C5 radiculopathy - defined in our study as the existence of preoperative deltoid muscle weakness in grade 3 or less by MMT - will be excluded. Any patients who have undergone previous cervical spine surgery, or who have any spinal malignancy, trauma or infection will be excluded in order to eliminate the confounding effect of multiple surgical interventions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023696


Contacts
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Contact: David Chelnick, BS 2164451741 chelnid2@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: David Chelnick, BS    216-445-1741    chelnid2@ccf.org   
Contact: Emily Fisher, MPH       fishere3@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
University of Southern California
Investigators
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Principal Investigator: Thomas E Mroz, MD The Cleveland Clinic
Publications:

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Responsible Party: Thomas Mroz, MD, Director, Center for Spine Health, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03023696    
Other Study ID Numbers: 16-353
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Mroz, MD, The Cleveland Clinic:
C5 Palsy
foraminotomy
Additional relevant MeSH terms:
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Paralysis
Radiculopathy
Spinal Cord Diseases
Spinal Cord Compression
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries