NCT07177651

Brief Summary

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.

Trial Health

65
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Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Oct 2025

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Oct 2025Mar 2027

First Submitted

Initial submission to the registry

July 2, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

October 4, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

July 2, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

LaminoplastyLateral mass fixation

Outcome Measures

Primary Outcomes (1)

  • Change in modified Japanese Orthopaedic Association (mJOA) score from baseline to 6 months (neurological function; range 0-17; higher = better function)

    Neurological outcome will be assessed using the modified Japanese Orthopaedic Association (mJOA) score, which evaluates motor and sensory function of the upper and lower extremities, as well as bladder function. Scores range from 0-17, with higher scores indicating better neurological function. Assessments will be performed at baseline (pre-operative), and at 6 months postoperatively by a blinded clinician.

    Baseline and 6 months postoperatively

Secondary Outcomes (2)

  • Complication rate within 90 days postoperatively

    Within 90 days postoperatively

  • Length of hospital stay (days)

    Perioperative period

Study Arms (2)

Laminoplasty

EXPERIMENTAL
Procedure: Laminoplasty

Laminectomy with lateral mass fixation

EXPERIMENTAL
Procedure: Laminectomy with lateral mass fixation

Interventions

LaminoplastyPROCEDURE

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

Laminoplasty

Posterior cervical decompression with lateral mass screw insertion

Laminectomy with lateral mass fixation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

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

    RESULT

Related Links

MeSH Terms

Interventions

LaminoplastyLaminectomy

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsNeurosurgical ProceduresSurgical Procedures, OperativeDecompression, Surgical

Study Officials

  • Mahmoud Hassan Ragab

    Assiut University hospital, neurosurgery department

    STUDY DIRECTOR
  • Abdel Hakeem Abdel Sattar

    Assiut University, neurosurgery department

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, specialist , neurosurgery department

Study Record Dates

First Submitted

July 2, 2025

First Posted

September 17, 2025

Study Start

October 4, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share