An interventional study of Uniportal Endoscopic Posterior Cervical Foraminotomy and Anterior Cervical Discectomy and Fusion in Cervical Disc Herniation, Cervical Foraminal Stenosis and Cervical Radiculopathy, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Treatment
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.
498 studies on the registry are indexed under Radiculopathy; 144 are open to participants now.
This study's planned enrollment of 46 is below the median of 60 across 385 interventional studies indexed under Radiculopathy.
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Exclusion Criteria:
Patients randomized to the experimental group will undergo uniportal endoscopic posterior cervical foraminotomy for the treatment of cervical radiculopathy caused by cervical disc herniation or foraminal stenosis. The procedure enables direct decompression of the affected nerve root without intervertebral fusion.
Procedure: Uniportal Endoscopic Posterior Cervical Foraminotomy
Patients randomized to the active comparator group will undergo anterior cervical discectomy and fusion (ACDF), an established surgical treatment for cervical radiculopathy. The procedure involves anterior cervical decompression of the affected nerve root followed by intervertebral fusion using an interbody cage.
Procedure: Anterior Cervical Discectomy and Fusion
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 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.
Also known as: ACDF
Upper Limb Radicular Pain Intensity at 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.
Time frame: 3 months after surgery
Upper Limb Radicular Pain Intensity at 6 Weeks Measured Using an 11-Point Numerical Rating Scale (0-10)
Time frame: 6 weeks after surgery
Upper Limb Radicular Pain Intensity at 6 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Time frame: 6 months after surgery
Upper Limb Radicular Pain Intensity at 9 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Time frame: 9 months after surgery
Upper Limb Radicular Pain Intensity at 12 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Time frame: 12 months after surgery
Cervical Pain Intensity at 6 Weeks Measured Using an 11-Point Numerical Rating Scale (0-10)
Time frame: 6 weeks after surgery
Cervical Pain Intensity at 3 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Time frame: 3 months after surgery
Cervical Pain Intensity at 6 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Time frame: 6 months after surgery
Cervical Pain Intensity at 9 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Time frame: 9 months after surgery
Cervical Pain Intensity at 12 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Time frame: 12 months after surgery
Neck Disability Index at 6 Weeks Measured using the Neck Disability Index questionnaire
Time frame: 6 weeks after surgery
Neck Disability Index at 3 Months Measured using the Neck Disability Index questionnaire
Time frame: 3 months after surgery
Neck Disability Index at 6 Months Measured using the Neck Disability Index questionnaire
Time frame: 6 months after surgery
Neck Disability Index at 9 Months Measured using the Neck Disability Index questionnaire
Time frame: 9 months after surgery
Neck Disability Index at 12 Months Measured using the Neck Disability Index questionnaire
Time frame: 12 months after surgery
Adjacent Segment Disc Degeneration
Proportion of Participants With Adjacent Segment Intervertebral Disc Signal Changes on MRI
Time frame: 12 months after surgery
Intervertebral Fusion
Proportion of Participants With Intervertebral Fusion on Cervical CT Intervertebral fusion will be assessed using cervical computed tomography (CT) performed 12 months after surgery in participants allocated to the anterior cervical discectomy and fusion group.
Time frame: 12 months after surgery
Postoperative Complications
Proportion of Participants Experiencing Surgical Complications
Time frame: From surgery through 12 months of postoperative follow-up
Operative Duration measured at the end of the surgery, from skin incision to completion of wound closure
Surgical procedure duration will be measured in minutes, from skin incision to completion of wound closure. The duration will be compared between the two treatment groups.
Time frame: Immediately after the surgery
Length of Hospital Stay
Length of hospital stay associated with the surgical procedure, measured in days, will be compared between the two treatment groups.
Time frame: From surgical admission to hospital discharge
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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