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

NCT07177651 — Not applicable, Not yet recruiting, 2 participants, Assiut University

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

RegistryNCT07177651
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment2 (Estimated)
SponsorAssiut University (Other)
ConditionsCervical Stenosis, Degenerative Cervical Spinal Stenosis
InterventionsLaminoplasty, Laminectomy with lateral mass fixation (Procedure)
Datesstart 2025-10-04 (estimated), primary completion 2026-05-01 (estimated), completion 2027-03-01 (estimated), first posted 2025-09-17, last updated 2025-09-17

Related Papers Related Patents Related Grants Related Experts
All trials for Cervical Stenosis All trials for Degenerative Cervical Spinal Stenosis All trials of Laminoplasty All trials of Laminectomy with lateral mass fixation

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
LaminoplastyExperimentalProcedure: Laminoplasty
Laminectomy with lateral mass fixationExperimentalProcedure: Laminectomy with lateral mass fixation
  • Laminoplasty (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 (Procedure): Posterior cervical decompression with lateral mass screw insertion

+Outcome measures

Primary outcomes

  • Change in modified Japanese Orthopaedic Association (mJOA) score from baseline to 6 months (neurological function; range 0-17; higher = better function) [Baseline and 6 months postoperatively]: 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.

Secondary outcomes

  • Complication rate within 90 days postoperatively [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.
  • Length of hospital stay (days) [Perioperative period]: Length of hospital stay will be recorded as the number of days from surgery to hospital discharge.

+Eligibility

Sex: All, ages: 40 Years to any

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.

+Publications

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

+Investigators