Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03023696

Can Prophylactic Foraminotomy Prevent C5 Palsy

Led by The Cleveland Clinic · Updated on 2026-01-22

480

Participants Needed

1

Research Sites

547 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Can Prophylactic Foraminotomy Prevent C5 Palsy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with cervical myelopathy without radiculopathy undergoing posterior cervical decompression involving the C4-C5 area
  • Patients scheduled for cervical laminoplasty or laminectomy and fusion
  • Patients treated at Cleveland Clinic between 2016 and 2018
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years due to skeletal immaturity
  • Patients with C5 radiculopathy defined as preoperative deltoid muscle weakness grade 3 or less by manual muscle test
  • Patients who have had previous cervical spine surgery
  • Patients with spinal malignancy, trauma, or infection

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

N

Nya Robinson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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