Cervical Disc HerniationENDOFORNCT07894159
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
A study testing Uniportal Endoscopic Posterior Cervical Foraminotomy and Anterior Cervical Discectomy and Fusion in people with Cervical Disc Herniation and Cervical Foraminal Stenosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Disc Herniation, Cervical Foraminal Stenosis, Cervical Radiculopathy
- What is being tested?
- Uniportal Endoscopic Posterior Cervical Foraminotomy and Anterior Cervical Discectomy and Fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Cervical radiculopathy associated with at least one of the following conditions:
- Cervical foraminal stenosis
- Lateral cervical disc herniation
- Foraminal cervical disc herniation
- Pre-foraminal cervical disc herniation
Show all 9Show fewer
- Eligible for either anterior cervical discectomy and fusion or uniportal endoscopic posterior cervical foraminotomy
- Affiliation with, or entitlement to benefits under, a French social security scheme
- Having received comprehensive information about the study and provided written informed consent
Who cannot join
- Median cervical disc herniation
- Cervical spondylotic myelopathy
- Spinal instability
- Spinal cord compression associated with intramedullary T2-weighted MRI hyperintensity
- Spondylolisthesis at the affected cervical level
- Neuropathic pain lasting longer than one year
Show all 13Show fewer
- Contraindication to either of the evaluated surgical strategies or associated medical devices
- Women of childbearing potential without effective contraception
- Pregnant, parturient, or breastfeeding women
- Individuals subject to legal protection measures, including guardianship or curatorship
- Adults unable to provide informed consent
- Individuals deprived of liberty by judicial or administrative decision
- Individuals receiving compulsory psychiatric care under the applicable provisions of French law
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Régional Universitaire de Nancy
Nancy, Grand Est, 54000
Insafe Mezjan, MD, +33 3 83 85 96 65, mezjan.insafe@outlook.com
About this study
Official title: A Prospective, Randomized, Open-Label, Controlled Non-Inferiority Trial Comparing Uniportal Endoscopic Posterior Cervical Foraminotomy With 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.
Read more
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.
- Being tested
- Uniportal Endoscopic Posterior Cervical Foraminotomy, Anterior Cervical Discectomy and Fusion
- Keywords
- Posterior cervical foraminotomy, Uniportal endoscopic spine surgery, Uniportal endoscopic posterior cervical foraminotomy, Anterior cervical discectomy and fusion, Cervical radiculopathy, Endoscopic cervical foraminotomy, Endoscopic posterior cervical foraminotomy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uniportal Endoscopic Posterior Cervical ForaminotomyProcedure or surgery
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 FusionProcedure or surgery
Also called ACDF
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 group | Role | What they receive |
|---|---|---|
| Uniportal Endoscopic Posterior Cervical Foraminotomy | Experimental | 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. Receives: Procedure: Uniportal Endoscopic Posterior Cervical Foraminotomy |
| Anterior Cervical Discectomy and Fusion | Active comparator | 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. Receives: Procedure: Anterior Cervical Discectomy and Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (19)
Upper Limb Radicular Pain Intensity at 6 Weeks Measured Using an 11-Point Numerical Rating Scale (0-10)
Measured: 6 weeks after surgery
Upper Limb Radicular Pain Intensity at 6 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Measured: 6 months after surgery
Upper Limb Radicular Pain Intensity at 9 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Measured: 9 months after surgery
Upper Limb Radicular Pain Intensity at 12 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Measured: 12 months after surgery
Cervical Pain Intensity at 6 Weeks Measured Using an 11-Point Numerical Rating Scale (0-10)
Measured: 6 weeks after surgery
Cervical Pain Intensity at 3 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Measured: 3 months after surgery
Cervical Pain Intensity at 6 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Measured: 6 months after surgery
Cervical Pain Intensity at 9 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Measured: 9 months after surgery
Cervical Pain Intensity at 12 Months Measured Using an 11-Point Numerical Rating Scale (0-10)
Measured: 12 months after surgery
Neck Disability Index at 6 Weeks Measured using the Neck Disability Index questionnaire
Measured: 6 weeks after surgery
Neck Disability Index at 3 Months Measured using the Neck Disability Index questionnaire
Measured: 3 months after surgery
Neck Disability Index at 6 Months Measured using the Neck Disability Index questionnaire
Measured: 6 months after surgery
Neck Disability Index at 9 Months Measured using the Neck Disability Index questionnaire
Measured: 9 months after surgery
Neck Disability Index at 12 Months Measured using the Neck Disability Index questionnaire
Measured: 12 months after surgery
Adjacent Segment Disc Degeneration
Proportion of Participants With Adjacent Segment Intervertebral Disc Signal Changes on MRI
Measured: 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.
Measured: 12 months after surgery
Postoperative Complications
Proportion of Participants Experiencing Surgical Complications
Measured: 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.
Measured: 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.
Measured: From surgical admission to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MEZJAN Insafe, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894159
- Sponsor's protocol ID
- 2024PI224
- Acronym
- ENDOFOR
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label, Controlled Non-Inferiority Trial Comparing Uniportal Endoscopic Posterior Cervical Foraminotomy With Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT07894159
- Acronym / sponsor ID
- ENDOFOR / 2024PI224
- Keywords
- Posterior cervical foraminotomy, Uniportal endoscopic spine surgery, Uniportal endoscopic posterior cervical foraminotomy, Anterior cervical discectomy and fusion, Cervical radiculopathy, Endoscopic cervical foraminotomy, Endoscopic posterior cervical foraminotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Uniportal Endoscopic Posterior Cervical Foraminotomy | Experimental | Procedure: Uniportal Endoscopic Posterior Cervical ForaminotomyPatients 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. |
| Anterior Cervical Discectomy and Fusion | Active comparator | Procedure: Anterior Cervical Discectomy and FusionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older
- Cervical radiculopathy associated with at least one of the following conditions:
- Cervical foraminal stenosis
- Lateral cervical disc herniation
- Foraminal cervical disc herniation
Key exclusion criteria (13 listed)
- Median cervical disc herniation
- Cervical spondylotic myelopathy
- Spinal instability
- Spinal cord compression associated with intramedullary T2-weighted MRI hyperintensity
- Spondylolisthesis at the affected cervical level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uniportal Endoscopic Posterior Cervical ForaminotomyUniportal 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. | Procedure or surgery | Uniportal Endoscopic Posterior Cervical Foraminotomy |
| Anterior Cervical Discectomy and FusionAlso: ACDFAnterior 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. | Procedure or surgery | Anterior Cervical Discectomy and Fusion |
Primary outcome
Upper Limb Radicular Pain Intensity at 3 Months After Surgery
Time frame: 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.
19 secondary outcomes
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
Time frame: 12 months after surgery
Intervertebral Fusion
Time frame: 12 months after surgery
Postoperative 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
Time frame: Immediately after the surgery
Length of Hospital Stay
Time frame: From surgical admission to hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uniportal Endoscopic Posterior Cervical Foraminotomy and Anterior Cervical Discectomy and Fusion in people with Cervical Disc Herniation and Cervical Foraminal Stenosis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insafe Mezjan, MD (+33 3 83 85 96 65, mezjan.insafe@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Radicular Pain Intensity at 3 Months After Surgery (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.