Prophylactic foraminotomy to prevent C5 palsy after cervical spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether performing a prophylactic bilateral foraminotomy during cervical decompression surgery can reduce the incidence of C5 palsy, a rare but debilitating complication. C5 palsy can lead to significant upper extremity weakness and sensory deficits, impacting patients' quality of life. The study will evaluate postoperative outcomes in patients diagnosed with cervical myelopathy who undergo this surgical intervention. By comparing muscle strength scores before and after surgery, the research aims to establish the effectiveness of this technique in preventing C5 palsy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Thomas E Mroz, MD — The Cleveland Clinic
• Study coordinator: Nya Robinson
• Email: ROBINSN8@ccf.org
• Phone: 2164441741

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.