NOT YET RECRUITING
NCT07894159
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
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.
Gender: All
Ages: 18 Years - Any
Cervical Disc Herniation
Cervical Foraminal Stenosis
Cervical Radiculopathy