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Not yet recruiting NCT06857643

Functional Outcome After Surgery for Cervical Disc Prolapse

Observational Cervical Disc Herniation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cervical Disc Herniation. Basic parameters: 18 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed description

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

Primary outcome measures

  • Percentage of improvement in The modified Japanese orthopedic association (mJOA) score [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Patients with degenerative cervical disc prolapse.

Exclusion criteria

  • Traumatic Cervical disc prolapse
  • Patients with ossification of the posterior longitudinal ligament (OPLL)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06857643 · Functional Outcome CDH Surgery

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗