Cervical StenosisNCT07177651
Laminoplasty Versus Laminectomy With Lateral Mass Fixation in Management of Degenerative Cervical Canal Stenosis
A study testing Laminoplasty and Laminectomy with lateral mass fixation in people with Cervical Stenosis and Degenerative Cervical Spinal Stenosis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cervical Stenosis, Degenerative Cervical Spinal Stenosis
- What is being tested?
- Laminoplasty and Laminectomy with lateral mass fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 4 Oct 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Fahd Abdel sabour Ahmed Fahd Abdel Sabour Ahmed, Master degree in neurosurgery contact
About this study
Official title: Comparative Study Between Laminoplasty Versus Laminectomy With Lateral Mass Fixation in Management of Degenerative Cervical Canal Stenosis
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.
Read the 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.
- Being tested
- Laminoplasty, Laminectomy with lateral mass fixation
- Keywords
- Laminoplasty, Lateral mass fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaminoplastyProcedure or 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 fixationProcedure or surgery
Posterior cervical decompression with lateral mass screw insertion
| Study group | Role | What they receive |
|---|---|---|
| Laminoplasty | Experimental | Not described Receives: Procedure: Laminoplasty |
| Laminectomy with lateral mass fixation | Experimental | Not described Receives: Procedure: Laminectomy with lateral mass fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months postoperatively
Secondary outcomes (2)
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.
Measured: Within 90 days postoperatively
Length of hospital stay (days)
Length of hospital stay will be recorded as the number of days from surgery to hospital discharge.
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start4 Oct 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical StenosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahd Abdel Sabour Ahmed Mohammed, Assiut University
- Investigators
- Mahmoud Hassan Ragab, Study director, Assiut University hospital, neurosurgery departmentAbdel Hakeem Abdel Sattar, Study director, Assiut University, neurosurgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177651
- Sponsor's protocol ID
- Posterior cervical approaches
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
https://www.asianspinejournal.org/journal/view.php?doi=10.4184%2Fasj.2016.10.3.536
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Laminoplasty Versus Laminectomy With Lateral Mass Fixation in Management of Degenerative Cervical Canal Stenosis
- ClinicalTrials.gov ID
- NCT07177651
- Acronym / sponsor ID
- Posterior cervical approaches
- Keywords
- Laminoplasty, Lateral mass fixation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Oct 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laminoplasty | Experimental | Procedure: Laminoplasty |
| Laminectomy with lateral mass fixation | Experimental | Procedure: Laminectomy with lateral mass fixation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaminoplastyIs 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 or surgery | Laminoplasty |
| Laminectomy with lateral mass fixationPosterior cervical decompression with lateral mass screw insertion | Procedure or surgery | Laminectomy with lateral mass fixation |
Primary outcome
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
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.
2 secondary outcomes
Complication rate within 90 days postoperatively
Time frame: Within 90 days postoperatively
Length of hospital stay (days)
Time frame: Perioperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Results publicationhttps://www.asianspinejournal.org/journal/view.php?doi=10.4184%2Fasj.2016.10.3.536
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cervical Stenosis
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Recruiting
Evaluation of the Statistical Validity of Cervical Spine Measurements-Including Range of Motion, Strength, and Functional Test Results-for Return to Sport in Patients Who Have Undergone Surgery for Cervical Stenosis and/or Herniation.
Cervical Stenosis, Cervical Spine
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Active, not recruitingPhase 2
Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Androgen Receptor Positive, Locally Advanced Salivary Gland Carcinoma
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fahd Abdel sabour Ahmed Fahd Abdel Sabour Ahmed, Master degree in neurosurgery contact
Mahmoud Hassan Ragab study director
Assiut University hospital, neurosurgery department
Abdel Hakeem Abdel Sattar study director
Assiut University, neurosurgery department
Questions about this trial
What is this clinical trial studying?
A study testing Laminoplasty and Laminectomy with lateral mass fixation in people with Cervical Stenosis and Degenerative Cervical Spinal Stenosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fahd Abdel sabour Ahmed Fahd Abdel Sabour Ahmed, Master degree in neurosurgery (00201029522851, Dfahd81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07177651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.