Cervical Disc ProlapseNCT06847503
Functional Outcome After Combined Posterior Laminectomy and Anterior Cervical Discectomy and Fusion for Large Cervical Disc Prolapse
An observational study of Cervical Disc Prolapse, run by Assiut University.
Trial summary
Cervical disc herniation (CDH) is the result of the displacement of the nucleus pulposus of the intervertebral disc, which may result in impingement of the traversing nerves as they exit the neural foramen or directly compressing the spinal cord contained within the spinal canal.[1] Eventually symptoms may arise… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Disc Prolapse
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 May 2027
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with degenerative large cervical disc prolapse and canal stenosis with myelopathy. (we defined large cervical disc prolapse as any cervical disc prolapse occupying 40% or more of the cervical spinal canal)
Who may be able to join
- Patients with degenerative large cervical disc prolapse and canal stenosis with myelopathy.
- (we defined large cervical disc prolapse as any cervical disc prolapse occupying 40% or more of the cervical spinal canal)
Who cannot join
- Cervical disc prolapse with wide canal
- Cervical disc prolapse with radiculopathy
- Traumatic Cervical disc prolapse
- Patients with ossification of the posterior longitudinal ligament (OPLL)
About this study
Cervical disc herniation (CDH) is the result of the displacement of the nucleus pulposus of the intervertebral disc, which may result in impingement of the traversing nerves as they exit the neural foramen or directly compressing the spinal cord contained within the spinal canal.[1] Eventually symptoms may arise because of a CDH with compression of the rootlet or spinal cord.[2] When conservative treatment for CDH fails, surgical treatment may be considered.[3] The main goals of surgical treatment are to remove pressure from the nerves, restore the alignment of the vertebrae, to stabilize the spine [3] and to prevent progression of neurological deficit in case of myelopathy.[4] Anterior cervical discectomy and fusion (ACDF) has proven to be an effective surgical intervention for both cervical radiculopathy and myelopathy and has become standard treatment for both of these disease states over the last half-century.[5] Certain reports have indicated that various complications are associated with ACDF namely, incomplete decompression, recurrence of myelopathy due to adjacent segment degeneration.[6] In cases where the stenosis is extensive, or attributed in part to congenital stenosis, the posterior approach may be advantageous to achieve more extensive decompression that would otherwise not be possible through an anterior approach.[7] Given that most stenosis occurs from anterior pathology, a posterior decompression works to indirectly relieve pressure on the spinal cord.[8] Misalignment and large anterior compression of the spinal cord can be risk factors for insufficient functional recovery in patients treated with posterior decompression alone.[9] In a study of 428 patients that were enrolled in a prospective cohort study to investigate the incidence, etiology, and outcomes of patients who experience neurological deterioration after surgery for degenerative cervical myelopathy(DCM), Evaniew et al[10] reported the incidence of deterioration after surgery for DCM was approximately one in ten (12%).
In this study we will perform combined posterior laminectomy and ACDF to avoid incomplete decompression and neurological deterioration after surgery. We aim to assess the functional outcome after combined posterior laminectomy and ACDF in patients with large cervical disc prolapse.
In this study we will perform combined posterior laminectomy and ACDF to avoid incomplete decompression and neurological deterioration after surgery. We aim to assess the functional outcome after combined posterior laminectomy and ACDF in patients with large cervical disc prolapse.
- Conditions
- Cervical Disc Prolapse
- Keywords
- Posterior Laminectomy, Anterior Cervical Discectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with degenerative large cervical disc prolapse and canal stenosis with myelopathy. (we defined large cervical disc prolapse as any cervical disc prolapse occupying 40% or more of the cervical spinal canal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of improvement in the modified Japanese Orthopaedic AssociationmJOA-AR scale.
It is an 18-point scale that addresses upper (5 points) and lower extremity (7 points) motor function, sensation (3 points) and micturition (3 points). A score of 18 reflects no neurological deficits whereas a lower score indicates a greater degree of disability and functional impairment. The mJOA is the second most commonly used outcome measure to quantify severity in patients with DCM
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc ProlapseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelrahman Zakaria Abdelrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847503
- Sponsor's protocol ID
- Post Laminectomy Ant Cervical
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome After Combined Posterior Laminectomy and Anterior Cervical Discectomy and Fusion for Large Cervical Disc Prolapse
- ClinicalTrials.gov ID
- NCT06847503
- Acronym / sponsor ID
- Post Laminectomy Ant Cervical
- Conditions
- Cervical Disc Prolapse
- Keywords
- Posterior Laminectomy, Anterior Cervical Discectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 26 Feb 2025 (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 disc herniation (CDH) is the result of the displacement of the nucleus pulposus of the intervertebral disc, which may result in impingement of the traversing nerves as they exit the neural foramen or directly compressing the spinal cord contained within the spinal canal.[1] Eventually symptoms may arise because of a CDH with compression of the rootlet or spinal cord.[2] When conservative treatment for CDH fails, surgical treatment may be considered.[3] The main goals of surgical treatment are to remove pressure from the nerves, restore the alignment of the vertebrae, to stabilize the spine [3] and to prevent progression of neurological deficit in case of myelopathy.[4] Anterior cervical discectomy and fusion (ACDF) has proven to be an effective surgical intervention for both cervical radiculopathy and myelopathy and has become standard treatment for both of these disease states over the last half-century.[5] Certain reports have indicated that various complications are associated with ACDF namely, incomplete decompression, recurrence of myelopathy due to adjacent segment degeneration.[6] In cases where the stenosis is extensive, or attributed in part to congenital stenosis, the posterior approach may be advantageous to achieve more extensive decompression that would otherwise not be possible through an anterior approach.[7] Given that most stenosis occurs from anterior pathology, a posterior decompression works to indirectly relieve pressure on the spinal cord.[8] Misalignment and large anterior compression of the spinal cord can be risk factors for insufficient functional recovery in patients treated with posterior decompression alone.[9] In a study of 428 patients that were enrolled in a prospective cohort study to investigate the incidence, etiology, and outcomes of patients who experience neurological deterioration after surgery for degenerative cervical myelopathy(DCM), Evaniew et al[10] reported the incidence of deterioration after surgery for DCM was approximately one in ten (12%).
In this study we will perform combined posterior laminectomy and ACDF to avoid incomplete decompression and neurological deterioration after surgery. We aim to assess the functional outcome after combined posterior laminectomy and ACDF in patients with large cervical disc prolapse.
In this study we will perform combined posterior laminectomy and ACDF to avoid incomplete decompression and neurological deterioration after surgery. We aim to assess the functional outcome after combined posterior laminectomy and ACDF in patients with large cervical disc prolapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Patients with degenerative large cervical disc prolapse and canal stenosis with myelopathy. (we defined large cervical disc prolapse as any cervical disc prolapse occupying 40% or more of the cervical spinal canal) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with degenerative large cervical disc prolapse and canal stenosis with myelopathy. (we defined large cervical disc prolapse as any cervical disc prolapse occupying 40% or more of the cervical spinal canal)
Key inclusion criteria (2 listed)
- Patients with degenerative large cervical disc prolapse and canal stenosis with myelopathy.
- (we defined large cervical disc prolapse as any cervical disc prolapse occupying 40% or more of the cervical spinal canal)
Key exclusion criteria (4 listed)
- Cervical disc prolapse with wide canal
- Cervical disc prolapse with radiculopathy
- Traumatic Cervical disc prolapse
- Patients with ossification of the posterior longitudinal ligament (OPLL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of improvement in the modified Japanese Orthopaedic AssociationmJOA-AR scale.
Time frame: 30 day
It is an 18-point scale that addresses upper (5 points) and lower extremity (7 points) motor function, sensation (3 points) and micturition (3 points). A score of 18 reflects no neurological deficits whereas a lower score indicates a greater degree of disability and functional impairment. The mJOA is the second most commonly used outcome measure to quantify severity in patients with DCM
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 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Prolapse, run by Assiut University.
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 2 inclusion and 4 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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of improvement in the modified Japanese Orthopaedic AssociationmJOA-AR scale. (time frame: 30 day). 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 Feb 2025.