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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-74
SponsorTecSalud Investigación Clínica

About this trial

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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Posterior Uniportal Endoscopic Cervical Decompression

    Procedure/Surgery

    Posterior Uniportal Endoscopic Cervical Decompression

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Cervical Spinal Stenosis Cases1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Assessed 7 days, 1 month, 3 months, 6 months, and 12 months postoperatively.

Other outcomes

Sponsors and contacts

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

TecSalud Investigación Clínica

Lead sponsor

Tecnologico de Monterrey

Collaborator

Centro Medico Nacional Siglo XXI IMSS

Collaborator

Hospital Ángeles Tijuana

Collaborator

Hospital Zambrano Hellion TecSalud, Mexico

Collaborator