Prophylactic Foraminotomy for C5 Palsy
Trial Summary
What is the purpose of this trial?
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.
Research Team
Thomas E Mroz, MD
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
This trial is for Cleveland Clinic patients aged 18 or older with cervical myelopathy, scheduled for posterior cervical decompression at the C4-C5 level between 2016 and 2018. Excluded are those with preoperative deltoid muscle weakness, previous neck surgery, spinal cancer, trauma, or infection.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cervical decompression surgery with or without prophylactic bilateral foraminotomy
Follow-up
Participants are monitored for C5 palsy and other complications post-surgery
Treatment Details
Interventions
- Bilateral Cervical Keyhole Foraminotomy
- Cervical Decompression
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
University of Southern California
Collaborator