Prophylactic foraminotomy to prevent C5 palsy after cervical spine surgery
A Randomized, Prospective Study Determining the Impact of Prophylactic Bilateral Foraminotomy During Cervical Decompression on C5 Palsy
This study tests if a specific surgical procedure can help prevent C5 palsy, which causes weakness in the arms, in patients having surgery for neck problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT03023696 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with cervical myelopathy who are scheduled for posterior cervical decompression surgery without pre-existing C5 radiculopathy.
Not a fit: Patients with preoperative deltoid muscle weakness or those who have undergone previous cervical spine surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of C5 palsy, improving recovery and quality of life for patients undergoing cervical spine surgery.
How similar studies have performed: While some literature suggests that bilateral foraminotomy may reduce the risk of C5 palsy, this study aims to provide more definitive evidence on its effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.