Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy

Condition(s) studied

Investigational drug(s) / intervention(s)

Uniportal Endoscopic Posterior Cervical Foraminotomy: Uniportal endoscopic posterior cervical foraminotomy will be performed under general anesthesia with fluoroscopic guidance. Following identification of the affected cervical level, an approximately 7-mm posterolateral cervical skin incision will be made. Sequential dilators will be introduced to access the posterior cervical structures while minimizing disruption of the paravertebral musculature. The procedure will be performed under direct endoscopic visualization with continuous saline irrigation. In cases of bony foraminal stenosis, targeted bone drilling at the lamina-facet junction will be performed to decompress the affected nerve root. If a herniated cervical disc is responsible for nerve root compression, the herniated disc material will be removed through the same endoscopic approach. No intervertebral fusion will be performed.

Anterior Cervical Discectomy and Fusion: Anterior cervical discectomy and fusion will be performed under general anesthesia with fluoroscopic guidance. A transverse cervical incision will be made through a skin crease in the anterior neck. Following exposure of the anterior cervical spine, the affected intervertebral disc will be removed to achieve neural decompression. The intervertebral space will then be prepared for fusion, and an interbody cage will be implanted to restore disc height and facilitate osseous fusion between the adjacent vertebral bodies.

Study summary

Cervical radiculopathy caused by cervical disc herniation or foraminal stenosis is a common condition that may result in upper limb pain, sensory disturbances, and motor deficits. Anterior cervical discectomy and fusion (ACDF) is an established surgical treatment, providing effective nerve root decompression. However, this procedure requires intervertebral fusion and may be associated with complications such as pseudarthrosis, adjacent segment degeneration, dysphagia, and recurrent laryngeal nerve injury.

Uniportal endoscopic posterior cervical foraminotomy (UEPCF) is a minimally invasive alternative that enables direct nerve root decompression without intervertebral fusion. This technique may preserve cervical segmental mobility and reduce approach-related morbidity. Nevertheless, prospective randomized evidence comparing uniportal endoscopic posterior cervical foraminotomy with ACDF remains limited.

ENDOFOR is a prospective, single-center, randomized, open-label, controlled non-inferiority trial designed to assess whether uniportal endoscopic posterior cervical foraminotomy is non-inferior to ACDF in reducing upper limb radicular pain three months after surgery.

A total of 46 patients with cervical radiculopathy related to cervical disc herniation or foraminal stenosis will be randomized in a 1:1 ratio to undergo either uniportal endoscopic posterior cervical foraminotomy or ACDF.

The primary outcome is upper limb radicular pain intensity at three months after surgery, assessed using a patient-reported 0-10 pain scale and adjusted for baseline pain intensity. Secondary outcomes include cervical pain, functional disability, postoperative complications, operative duration, length of hospital stay, adjacent segment disc degeneration, and fusion status.

Patients will be followed for 12 months after surgery. The study aims to provide prospective randomized evidence regarding the effectiveness and safety of a minimally invasive surgical alternative to cervical fusion.

Eligibility

Primary outcome measure(s)

• Upper Limb Radicular Pain Intensity at 3 Months After Surgery — 3 months after surgery
  Upper limb radicular pain intensity will be assessed using a patient-reported 0-10 pain scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less severe pain. The primary analysis will compare pain intensity between the two surgical groups at three months after surgery, adjusting for baseline preoperative pain intensity using analysis of covariance (ANCOVA). The non-inferiority margin is set at 1 point on the 0-10 pain scale. Non-inferiority will be demonstrated if the upper bound of the 95% confidence interval for the adjusted mean difference (endoscopic foraminotomy minus ACDF) is below +1 point.

Trial sites (1)

More Central Hospital, Nancy, France trials in France