Can Prophylactic Foraminotomy Prevent C5 Palsy

Launched by THE CLEVELAND CLINIC · Jan 13, 2017

Keywords

ClinConnect Summary

This clinical trial is studying whether a specific surgical technique called bilateral foraminotomy can help prevent a rare but serious complication known as C5 palsy (C5P) that can occur after cervical spine surgery. C5 palsy can lead to significant weakness in the arms and shoulders, along with pain and sensory issues, which can greatly affect a person's daily life. Researchers aim to find out if adding this technique during surgery reduces the chances of patients developing C5P.

To participate in the trial, patients must be between the ages of 65 and 74 and have a diagnosis of cervical myelopathy, a condition caused by pressure on the spinal cord, but without any nerve root issues (known as radiculopathy). Patients who have had previous neck surgery, or have certain medical conditions like tumors or infections, will not be eligible. Those who join the study will undergo cervical decompression surgery and will be monitored to see if the foraminotomy helps protect them from developing C5P. The trial is being conducted at several leading medical centers, ensuring a thorough evaluation of this technique's effectiveness.

Gender

ALL

Eligibility 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.