Functional Outcome After Surgery for Cervical Disc Prolapse
1 other identifier
observational
30
0 countries
N/A
Brief 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 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 this study we will perform ACDF for patients with CDH occupying less than 50% of cervical canal and combined posterior laminectomy and ACDF for patients with CDH occupying 50% or more of the cervical canal with canal stenosis.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 this study we will perform ACDF for patients with CDH occupying less than 50% of cervical canal and combined posterior laminectomy and ACDF for patients with CDH occupying 50% or more of the cervical canal with canal stenosis. the aim of the study to Assessment of the functional outcome after surgery for cervical disc prolapse
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for all trials
Started Mar 2025
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedFirst Posted
Study publicly available on registry
March 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 4, 2025
February 1, 2025
1 year
February 27, 2025
February 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of improvement in The modified Japanese orthopedic association (mJOA) score
The modified Japanese Orthopaedic Association (mJOA) score is an investigator-administered tool used to evaluate neurological function in patients with DCM . 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
3 months
Study Arms (1)
Cervical disc herniation
Patients with degenerative cervical disc prolapse. patients who are subjected to Anterior cervical discectomy and fusion for patients with CDH occupying less than 50% of cervical canal and combined posterior laminectomy and Anterior cervical discectomy and fusion for patients with CDH occupying 50% or more of the cervical canal with canal stenosis
Eligibility Criteria
atients with degenerative cervical disc prolapse who underwint ACDF for patients with CDH occupying less than 50% of cervical canal and combined posterior laminectomy and ACDF for patients with CDH occupying 50% or more of the cervical canal with canal stenosi
You may qualify if:
- Patients with degenerative cervical disc prolapse.
You may not qualify if:
- Traumatic Cervical disc prolapse
- Patients with ossification of the posterior longitudinal ligament (OPLL)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- residant doctor
Study Record Dates
First Submitted
February 27, 2025
First Posted
March 4, 2025
Study Start
March 1, 2025
Primary Completion
March 1, 2026
Study Completion
May 1, 2026
Last Updated
March 4, 2025
Record last verified: 2025-02