Laminoplasty Versus Laminectomy With Lateral Mass Fixation in Management of Degenerative Cervical Canal Stenosis

NCT ID: NCT07177651

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-04

Study Completion Date

2027-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cervical canal stenosis (CCS) is a condition characterized by the narrowing of the spinal canal in the cervical spine, leading to compression of the spinal cord and nerve roots. This can result in a variety of neurological deficits, including myelopathy, radiculopathy, and motor dysfunction. The primary goal of treatment is to relieve neural compression and improve or preserve neurological function. Surgical decompression, such as laminoplasty, is a common procedure to treat this condition, as it decompresses the spinal canal to relieve pressure on the spinal cord. Laminectomy with lateral mass fixation is another option of management.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cervical canal stenosis (CCS) is a condition characterized by the narrowing of the spinal canal in the cervical spine, leading to compression of the spinal cord and nerve roots. This can result in a variety of neurological deficits, including myelopathy, radiculopathy, and motor dysfunction. The primary goal of treatment is to relieve neural compression and improve or preserve neurological function. Surgical decompression, such as laminoplasty, is a common procedure to treat this condition, as it decompresses the spinal canal to relieve pressure on the spinal cord.

Laminoplasty is a posterior approach that involves the surgical widening of the spinal canal by reshaping or repositioning the lamina. However, some patients with cervical stenosis, particularly those with accompanying spinal instability or degenerative changes, may not achieve satisfactory outcomes with laminoplasty alone. In such cases, lateral mass fixation is often added to provide supplemental stability to the spine, potentially preventing postoperative deformities and enhancing long-term outcomes

Lateral mass fixation is often combined with posterior decompression and typically done as part of a posterior cervical fusion where screws are placed into the lateral masses (bony structures on the sides of the vertebrae) to stabilize the cervical spine after decompression, such as through a laminectomy. This procedure sacrifices some motion for stability.

A comparative study is needed to better understand the advantages and disadvantages of each approach, in order to guide clinical decision-making and improve patient outcomes.

The general aim is to evaluate and compare the clinical outcomes, safety, and effectiveness of both surgical techniques in managing this condition.

The specific aim is to compare the clinical efficacy, assess the radiological outcomes, evaluate the surgical and postoperative complication and investigate long-term outcomes and instability.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Stenosis Degenerative Cervical Spinal Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laminoplasty

Group Type EXPERIMENTAL

Laminoplasty

Intervention Type PROCEDURE

Is a posterior approach that involves the surgical widening of the spinal canal by reshaping or repositioning the lamina. However, some patients with cervical stenosis

Laminectomy with lateral mass fixation

Group Type EXPERIMENTAL

Laminectomy with lateral mass fixation

Intervention Type PROCEDURE

Posterior cervical decompression with lateral mass screw insertion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laminoplasty

Is a posterior approach that involves the surgical widening of the spinal canal by reshaping or repositioning the lamina. However, some patients with cervical stenosis

Intervention Type PROCEDURE

Laminectomy with lateral mass fixation

Posterior cervical decompression with lateral mass screw insertion

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged 40 ≥ years with clinically significant cervical canal stenosis (based on imaging and neurological symptoms).
* Surgical indication for cervical decompression.
* Adequate follow up data (minimum 1 year).
* Patients fit for surgery.

Exclusion Criteria

* Patients unfit for surgery or contraindication to general anaesthesia.
* Congenital deformities or significant spinal deformities unrelated to stenosis.
* Patients with cervical kyphosis, active infection or known allergy to titanium.
* Previous cervical spine surgery.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fahd Abdel Sabour Ahmed Mohammed

Principal investigator, specialist , neurosurgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mahmoud Hassan Ragab

Role: STUDY_DIRECTOR

Assiut University hospital, neurosurgery department

Abdel Hakeem Abdel Sattar

Role: STUDY_DIRECTOR

Assiut University, neurosurgery department

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fahd Abdel sabour Ahmed Fahd Abdel Sabour Ahmed, Master degree in neurosurgery

Role: CONTACT

00201029522851

References

Explore related publications, articles, or registry entries linked to this study.

https://www.asianspinejournal.org/journal/view.php?doi=10.4184%2Fasj.2016.10.3.536

Reference Type RESULT

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Posterior cervical approaches

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cervical Spondylotic Myelopathy Surgical Trial
NCT02076113 ACTIVE_NOT_RECRUITING NA