跳至主要内容
临床试验/NCT03023696
NCT03023696招募中不适用

A Randomized, Prospective Study Determining the Impact of Prophylactic Bilateral Foraminotomy During Cervical Decompression on C5 Palsy

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
480
试验地点
2
主要终点
C5 Palsy

研究概览

简要总结

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.

详细描述

Introduction:

C5 palsy (C5P) is a well-known, although rare complication of cervical spine decompression surgery.1,2 In severe forms, C5P causes debilitating upper extremity weakness involving the deltoids and/or biceps brachii muscles, ultimately diminishing these patients' quality of life.3 Furthermore, about half of patients with C5P present with sensory deficits and/or intractable pain in addition to the muscle weakness.5 Fortunately, almost all cases of C5P present unilaterally. The deficit is typically quantified and diagnosed using each patient's manual muscle test (MMT) score (rating 0-5). The American Medical Association impairment rating guide grades the MMT as follows: Grade 0 = no perceptible muscle contraction; Grade 1 = muscle contraction palpable, but no motion; Grade 2 = motion of the part only with gravity reduced; Grade 3 = muscle can hold the part in the test position against gravity alone; Grade 4 = patient can move the part through the full range of active motion against "some" resistance; Grade 5 = patient can move the part through the full active range of motion against "full" resistance. C5P is defined as: a reduction of at least 1 in deltoid and/or biceps brachii scores compared to preoperative scores, without any deterioration of myelopathic symptoms.5

Although a uniform understanding of the etiology and mechanism of C5P is not yet established, certain hypotheses have gained recognition. One prominent hypothesis, called the tethering phenomenon, suggests that following decompression, posterior shift of the cord produces traction on the nerve root resulting in a nerve root lesion. Other, less agreed upon hypotheses include: inadvertent injury to the nerve root during surgery, spinal cord ischemia, segmental spinal cord disorder, and reperfusion injury of the spinal cord. As the pathogenesis of C5P is uncovered, concerted efforts to minimize the incidence of this unfortunate complication have been undertaken.5

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.6,7,8 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.

Background:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • This includes patients undergoing cervical laminoplasty and cervical laminectomy and fusion.

排除标准

  • 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.

结局指标

主要结局

C5 Palsy

时间窗: Upon discharge, 2 weeks postoperatively and 3 months postoperatively

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.

次要结局

  • Preoperative anatomic measurements(Preoperative)
  • Blood loss(Intra-operative measurement)
  • Back Pain(Preoperative, 2 weeks postoperative and 3 months postoperative)
  • Leg Pain(Preoperative, 2 weeks postoperative and 3 months postoperative)
  • Emergency department visit(within 90 days postoperatively)
  • Readmission to hospital(within 90 days postoperatively)
  • Operative time(Intra-operative measurement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Mroz, MD

Institute Chair

The Cleveland Clinic

研究点 (2)

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