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Study identifier: NCT03023696 Synced from ClinicalTrials.gov · July 28, 2026
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Can Prophylactic Foraminotomy Prevent C5 Palsy

Condition: Myelopathy, Compressive · Radiculopathy, Cervical · C5 Palsy  ·  Sponsor: The Cleveland Clinic

PhaseNA
Planned participants480
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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: Clevela…

This description comes directly from the study's public registry record.

Talk to the study team

Nya Robinson  ·  2164441741  ·  ROBINSN8@ccf.org

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Locations (1)

Cleveland Clinic FoundationCleveland, Ohio, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT03023696