NCT06857643

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 27, 2025

Last Update Submit

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

Age18 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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