- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06847503
Functional Outcome After Combined Posterior Laminectomy and Anterior Cervical Discectomy and Fusion for Large Cervical Disc Prolapse
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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)
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Cervical disc prolapse with wide canal
- Cervical disc prolapse with radiculopathy
- Traumatic Cervical disc prolapse
- Patients with ossification of the posterior longitudinal ligament (OPLL)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
30 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Post Laminectomy Ant Cervical
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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Clinical Trials on Cervical Disc Prolapse
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Mansoura UniversityCompleted
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Assiut UniversityUnknownLumbar Disc Herniation
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Noha Khaled ShoukryCompleted
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Centinel SpineAvaniaEnrolling by invitationDegenerative Disc Disease | Symptomatic Cervical Disc Disease | Cervical Spine Degenerative Disc Disease | Cervical Spine Degenerative DiseaseGermany
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October 6 UniversityRecruiting