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Not yet recruiting NCT07177651

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

No phase Interventional Cervical Stenosis Degenerative Cervical Spinal Stenosis

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
The protocol lists: Laminoplasty, Laminectomy with lateral mass fixation.
Who it may be relevant to
Registry conditions: Cervical Stenosis, Degenerative Cervical Spinal Stenosis. Basic parameters: from 40 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 →
Official title

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

Overview

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

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.

Interventions

  • Procedure 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
  • Procedure Laminectomy with lateral mass fixation
    Posterior cervical decompression with lateral mass screw insertion

Primary outcome measures

  • Change in modified Japanese Orthopaedic Association (mJOA) score from baseline to 6 months (neurological function; range 0-17; higher = better function) [Time frame: Baseline and 6 months postoperatively]
Secondary outcome measures (2)
  • Complication rate within 90 days postoperatively [Time frame: Within 90 days postoperatively]
  • Length of hospital stay (days) [Time frame: Perioperative period]

Eligibility criteria

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.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

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

Identifiers

NCT: NCT07177651 · Posterior cervical approaches

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗