NCT03023696 Can Prophylactic Foraminotomy Prevent C5 Palsy
| NCT ID | NCT03023696 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Myelopathy, Compressive |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2016-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 480 participants in total. It began in 2016-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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: Cleveland Clinic, Columbia University Medical Center, and University of Southern California Spine Center. Patients undergoing cervical decompression surgery will be consented and enrolled if they meet the inclusion and exclusion criteria. Subsequently, incidence of C5P will be monitored to determine efficacy of prophylactic C5 bilateral foraminotomy during cervical decompression.
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.
Contact & Investigator
Thomas E Mroz, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT03023696 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelopathy, Compressive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03023696 currently recruiting?
Yes, NCT03023696 is actively recruiting participants. Contact the research team at ROBINSN8@ccf.org for enrollment information.
Where is the NCT03023696 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT03023696 clinical trial?
NCT03023696 is sponsored by The Cleveland Clinic. The principal investigator is Thomas E Mroz, MD at The Cleveland Clinic. The trial plans to enroll 480 participants.