Health TrialsbyHealthPanel

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

ConditionsCervical StenosisDegenerative Cervical Spinal Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laminoplasty

    Procedure/Surgery

    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

    Procedure/Surgery

    Posterior cervical decompression with lateral mass screw insertion

Treatment groups

2 Participants
are divided into 2 treatment groups
Group A: LaminoplastyExperimental treatment 1 intervention
Group B: Laminectomy with lateral mass fixationExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline and 6 months postoperatively

Secondary outcomes

1

Complication rate within 90 days postoperatively

All perioperative complications will be recorded within 90 days of surgery, including but not limited to surgical site infection (CDC criteria), C5 palsy (new postoperative motor deficit in deltoid/biceps), cerebrospinal fluid leak, and reoperation for any cause.

Time frame
Within 90 days postoperatively
2

Length of hospital stay (days)

Length of hospital stay will be recorded as the number of days from surgery to hospital discharge.

Time frame
Perioperative period

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: