Functional Outcome After Combined Posterior Laminectomy and Anterior Cervical Discectomy and Fusion for Large Cervical Disc Prolapse

February 21, 2025 updated by: Mohamed Abdelrahman Zakaria Abdelrahman, Assiut University

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

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Disc Prolapse

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