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

What this Trial Is About

Researchers are investigating C5 palsy (C5P), a rare but serious complication that can occur after cervical spine decompression surgery. This condition causes weakness in certain shoulder and arm muscles and may also lead to sensory problems and pain, reducing patients' quality of life. The study aims to evaluate whether performing a preventive bilateral foraminotomy at the C5 level during surgery can reduce the chance of developing C5P, as current evidence is suggestive but not conclusive. This trial is a randomized, prospective, multicenter study including patients undergoing various types of cervical decompression surgery such as laminoplasty, laminectomy, and fusion. Participants will be randomized to receive either standard cervical decompression surgery alone or decompression plus a prophylactic bilateral cervical keyhole foraminotomy. The foraminotomy procedure uses microscopic tools to carefully enlarge the nerve root exit area while preserving spine stability by limiting facet bone removal. The study will monitor the incidence of postoperative C5 palsy and other surgical outcomes. This approach is being assessed across multiple respected medical centers to determine its effectiveness and safety. During the study, participants will undergo evaluations including manual muscle testing before and after surgery to detect any muscle weakness. Researchers will collect clinical data such as operative time, blood loss, pain levels, hospital readmissions, and emergency visits. Anatomical measurements from imaging studies will also be analyzed. Follow-up assessments will occur at discharge, 2 weeks, and 3 months after surgery to track nerve function and recovery. The total study duration includes surgery and postoperative monitoring, ensuring comprehensive evaluation of the procedure's impact on C5 palsy rates.

Can Prophylactic Foraminotomy Prevent C5 Palsy