About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Bilateral Cervical Keyhole Foraminotomy
Procedure/SurgeryUnder microscopic or loop magnification, a high-speed burr is used to perform the foraminotomy. The keyhole foraminotomy begins at the lamina-facet junction, with careful consideration of the amount of facet resection. Typically, only the medial one third is drilled. Then a 1- or 2-mm Kerrison punch can be carefully placed over the nerve root and then used to undercut the facet, ensuring that the spine is not destabilized by the foraminotomy. The amount of facet resection must not exceed 50% in order to preserve spine stability.
Cervical Decompression
Procedure/SurgeryCervical decompression for myelopathy, including the following procedures: laminoplasty, laminectomy, discectomy and fusion
Treatment groups
Trial outcomes
Primary outcomes
C5 Palsy
Using manual muscle testing and upper extremity sensory exam findings to determine C5 palsy status. C5P is defined as: a reduction of at least 1 in deltoid and/or biceps brachii manual muscle testing scores compared to preoperative scores, without any deterioration of myelopathic symptoms.
Secondary outcomes
Preoperative anatomic measurements
Anteroposterior diameter, foraminal diameter and cord-lamina angle will be determined using preoperative computed tomography scan
Operative time
Time length of operation
Blood loss
Amount of blood loss during surgery
Back Pain
Visual Analog Scale for Back Pain (0-10)
Sponsors and contacts
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