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Spinal Stenosis CervicalDEC-SCMNCT06886802

Multicentric Case Series of Uniportal Endoscopic Posterior Cervical Decompression for Cervical Spinal Stenosis

An observational study of Spinal Stenosis Cervical, run by TecSalud Investigación Clínica at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Cervical spinal stenosis is a condition that can cause pain, sensory disturbances, and motor deficits due to the compression of neural structures in the cervical spine. While conservative treatments such as physical therapy and pain management can help some patients, others with persistent neurological deficits may… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Spinal Stenosis Cervical
What is being tested?
Posterior Uniportal Endoscopic Cervical Decompression
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteMexico
Study dates
18 Feb 2026to Feb 2027
Phase
Observational
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 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: • Patients with cervical spinal stenosis who continue to experience symptoms despite receiving complete conservative management for at least 3 months and who have chosen to undergo posterior uniportal endoscopic cervical decompression will be recruited consecutively. Recruitment will take place at the following healthcare centers: * Centro Médico Zambrano-Hellion, TecSalud (San Pedro Garza García, N.L.) and Clínica Cuauhtémoc y Famosa (Monterrey, N.L.) Patients will be recruited by Dr. Mario Benvenutti Regato, a neurosurgery specialist with over 7 years of experience performing endoscopic spine surgery. * Centro Médico Nacional Siglo XXI (Mexico City) Patients will be recruited by Dr. Félix Domínguez Cortinas, a neurosurgery specialist with over 10 years of experience performing endoscopic spine surgery. * Hospital Ángeles Tijuana (Tijuana, B.C.) Patients will be recruited by Dr. Alfonso García Chávez, a specialist in traumatology and orthopedics with over 10 years of experience perfor

Who may be able to join

  • Provision of informed consent to participate in the study.
  • Patients with cervical canal stenosis grade I-III according to the Kang scale.
  • Radicular or myelopathic symptoms.
  • Having undergone complete conservative management, including physical therapy and analgesia, for at least 3 months.
  • Patients who have opted for posterior uniportal endoscopic cervical decompression for cervical canal stenosis.

Who cannot join

  • Inability to read or write.
  • Prior cervical surgeries at the levels to be treated.
  • Infectious symptoms or concomitant rheumatologic diseases.
  • Criteria of cervical vertebral instability.
  • Congenital spinal malformations.
  • Disc herniation at the same cervical level to be operated on.
  • Medullary hyperintensity on T2-weighted magnetic resonance imaging in the level(s) to be treated.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

► Mario Benvenutti Regato, MD contact

(+52) 81 8888 0675

mbenreg@tec.mx

Mexico1 site, 1 recruiting
  • Hospital Zambrano Hellion, TecSalud

    San Pedro Garza García, Nuevo León, 66278

    Mario Benvenutti Regato, MD, (+52) 81 8888 0675, mbenreg@tec.mx

    Mario Benvenutti Regato, MD

    Recruiting

Other trials in Mexico

About this study

Cervical spinal stenosis is a condition that can cause pain, sensory disturbances, and motor deficits due to the compression of neural structures in the cervical spine. While conservative treatments such as physical therapy and pain management can help some patients, others with persistent neurological deficits may require surgical intervention. Traditional surgical approaches, including anterior decompression and posterior open surgery, have proven effective but carry risks such as vascular or nerve injuries and postoperative pain.

This study evaluates a minimally invasive surgical approach called Posterior Uniportal Endoscopic Cervical Decompression as an alternative to traditional methods for patients with cervical spinal stenosis. The main objective is to assess changes in neurological deficits and disability related to cervical pain following this procedure. The study will also document hospitalization duration, surgical time, blood loss, and the incidence of postoperative complications.

Read more

This multicenter, prospective case series will recruit 50 patients from three medical centers in Mexico. Participants must have symptomatic cervical spinal stenosis that persists despite at least three months of conservative treatment. Eligible patients will undergo Posterior Uniportal Endoscopic Cervical Decompression, a technique that allows precise nerve decompression through a small incision, minimizing damage to surrounding tissues. Standardized clinical assessment tools, including the modified Japanese Orthopaedic Association (mJOA) scale, Neck Disability Index (NDI), and Visual Analog Scale (VAS) for pain, will be used to evaluate outcomes at multiple time points over 12 months.

By comparing patients' preoperative and postoperative evaluations, the study aims to determine whether Posterior Uniportal Endoscopic Cervical Decompression effectively improves neurological function and reduces disability while maintaining a favorable safety profile. Findings from this study could support the adoption of minimally invasive endoscopic techniques as a viable option for treating cervical spinal stenosis, potentially leading to faster recovery times and reduced surgical complications compared to traditional methods.

Read the detailed description

Cervical spinal stenosis is a condition characterized by the narrowing of the cervical spinal canal, leading to compression of the neural structures. This can cause chronic pain, sensory disturbances, and motor deficits, significantly impairing the quality of life. While conservative management, including physical therapy, analgesics, and steroid injections, can provide symptomatic relief for some patients, others with persistent neurological deficits may require surgical intervention. Traditional surgical techniques, such as anterior cervical decompression and fusion or posterior open decompression, have been effective but carry risks such as vascular injury, neurological complications, and postoperative pain.

This study investigates the use of Posterior Uniportal Endoscopic Cervical Decompression, a minimally invasive surgical approach that offers targeted decompression through a single small incision while minimizing tissue disruption. The primary objective of the study is to evaluate changes in neurological deficits and disability related to cervical pain following this procedure. Secondary objectives include assessing the duration of hospitalization, surgical time, blood loss, and the incidence of postoperative complications.

This multicenter, prospective case series will recruit 50 patients diagnosed with cervical spinal stenosis at three medical institutions in Mexico. The study will be conducted over a period of 24 months, with an initial 12-month patient recruitment phase, followed by postoperative follow-up assessments at predetermined time intervals up to one year.

Participants will undergo Posterior Uniportal Endoscopic Cervical Decompression, a technique designed to preserve spinal mobility while reducing compression on the nerve roots. The procedure will be performed under general anesthesia with continuous neurophysiological monitoring, including somatosensory evoked potentials, motor evoked potentials, and continuous electromyography. Using a working-channel endoscope, surgeons will perform foraminotomies or laminotomies to remove compressive elements such as osteophytes, hypertrophic ligaments, or herniated disc material. The technique is aimed at achieving decompression with minimal disruption to the surrounding soft tissues.

Patients must meet specific inclusion criteria, including an age range of 18 to 75 years, confirmed diagnosis of cervical spinal stenosis (Kang classification grade I-III), and the presence of neurological symptoms unresponsive to at least three months of conservative management. Exclusion criteria include prior cervical surgery at the affected level, active infections, systemic inflammatory diseases, vertebral instability, congenital spinal malformations, and contraindications for general anesthesia.

Patient outcomes will be systematically evaluated using validated clinical assessment tools, including:

  • Modified Japanese Orthopaedic Association (mJOA) Scale - to assess neurological function.
  • Neck Disability Index (NDI) - to measure the impact of cervical pain on daily activities.
  • Visual Analog Scale (VAS) for pain - to quantify cervical and upper limb pain intensity.
  • EQ-5D-5L health-related quality of life questionnaire - to evaluate overall well-being.
  • Modified MacNab Criteria - to determine patient satisfaction with surgical outcomes.

Descriptive statistical methods will be used to analyze demographic and clinical characteristics of the study population. Changes in primary and secondary outcomes will be evaluated using paired t-tests for continuous variables and Chi-square tests for categorical variables. The impact of the procedure on neurological function and pain relief will be assessed through longitudinal comparisons between baseline and follow-up assessments at 1, 3, 6, and 12 months postoperatively. The incidence of complications will be categorized using the Clavien-Dindo classification, and the Comprehensive Complication Index will be used to quantify cumulative morbidity.

This study complies with the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, and national regulatory requirements. All participants will provide written informed consent before enrollment, and patient confidentiality will be maintained through data pseudonymization. The study has been approved by the Ethics Committees of the participating institutions.

The expected impact of this study is to generate clinical evidence supporting Posterior Uniportal Endoscopic Cervical Decompression as a safe and effective alternative to traditional surgical approaches for cervical spinal stenosis.

Being tested
Posterior Uniportal Endoscopic Cervical Decompression
Keywords
Cervical Spinal Stenosis, ► Minimally Invasive Surgical Procedures, ► Endoscopic Spine Surgery, ► Spinal Degenerative Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Posterior Uniportal Endoscopic Cervical DecompressionProcedure or surgery

    Posterior Uniportal Endoscopic Cervical Decompression

Study groups in NCT06886802
Study groupRoleWhat they receive
Cervical Spinal Stenosis CasesPatients diagnosed with cervical spinal stenosis who exhibit persistent neurological deficits and pain despite receiving at least three months of conservative treatment. All participants have elected to undergo Posterior Uniportal Endoscopic Cervical Decompression. They are being prospectively followed to evaluate improvements in neurological function and reductions in pain-related disability, as well as to document perioperative outcomes including surgical time, blood loss, hospital stay, and complications.
Receives: Procedure: Posterior Uniportal Endoscopic Cervical Decompression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cervical Disability (Neck Disability Index)

    This measure assesses disability related to cervical pain using the Neck Disability Index (NDI), a validated instrument scored from 0 (no disability) to 100 (maximum disability). It quantifies the impact of cervical pain on daily activities and overall function. Changes in NDI scores over time will reflect the effectiveness of the surgical intervention in reducing pain-related disability.

    Measured: Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.

  2. Change in Neurological Function (Modified Japanese Orthopaedic Association Score)

    This measure evaluates neurological function using the Modified Japanese Orthopaedic Association (mJOA) scale. The mJOA score, which ranges from 0 (severe neurological deficits) to 18 (normal neurological function), assesses motor function, sensory deficits, and gait. Improvements in the mJOA score following surgery will be used as an indicator of enhanced neurological status.

    Measured: Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.

Secondary outcomes (4)
  1. Duration of Hospitalization

    This metric records the total number of days from patient admission until discharge following the surgical procedure. It serves as an indicator of the immediate postoperative recovery and overall efficiency of the surgical intervention.

    Measured: Measured during the index hospitalization.

  2. Duration of Surgery

    This outcome measures the surgical time, defined as the period from the initial incision to the final closure of the surgical site. It reflects procedural efficiency and may indirectly indicate the technical ease or complexity of the procedure.

    Measured: Recorded intraoperatively.

  3. Intraoperative Blood Loss

    This measure quantifies the volume of blood lost during the surgical procedure, as collected via standard suction devices and measured in milliliters. It is an important indicator of surgical safety and efficiency.

    Measured: Assessed during the surgical procedure.

  4. Rate of Perioperative Complications

    This measure records the incidence and severity of complications occurring during the perioperative period. Complications will be categorized according to the Clavien-Dindo classification and summarized using the Comprehensive Complication Index, providing a quantitative assessment of overall surgical morbidity.

    Measured: Assessed 7 days, 1 month, 3 months, 6 months, and 12 months postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start18 Feb 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06886802
Sponsor's protocol ID
DEC-SCM
Acronym
DEC-SCM
Status last verified
Mar 2026
First submitted
13 Mar 2025
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ye ZY, Kong WJ, Xin ZJ, Fu Q, Ao J, Cao GR, Cai YQ, Liao WB. Clinical Observation of Posterior Percutaneous Full-Endoscopic Cervical Foraminotomy as a Treatment for Osseous Foraminal Stenosis. World Neurosurg. 2017 Oct;106:945-952. doi: 10.1016/j.wneu.2017.07.085. Epub 2017 Jul 21.

    PubMed 28739520
  • Lv J, Mei J, Feng X, Tian X, Sun L. Clinical efficacy and safety of posterior minimally invasive surgery in cervical spondylosis: a systematic review. J Orthop Surg Res. 2022 Aug 13;17(1):389. doi: 10.1186/s13018-022-03274-3.

    PubMed 35964065
  • Metzger RL. Evidence-based diagnosis and treatment of cervical spine disorders. Nurse Pract. 2019 Aug;44(8):30-37. doi: 10.1097/01.NPR.0000574648.67659.09.

    PubMed 31268958

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Stenosis Cervical, run by TecSalud Investigación Clínica at 1 site in Mexico.

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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

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 ► Mario Benvenutti Regato, MD ((+52) 81 8888 0675, mbenreg@tec.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cervical Disability (Neck Disability Index) (time frame: Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.). The study lists 2 primary outcomes in all. 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 NCT06886802, which also lists 3 linked publications.

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 4 Mar 2026.

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