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

NCT06886802 | Recruiting

• 1 other identifier: DEC-SCM
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Spinal Stenosis Cervical

Keywords

Cervical Spinal Stenosis; ► Minimally Invasive Surgical Procedures; ► Endoscopic Spine Surgery; ► Spinal Degenerative Disease

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (4)

• Duration of Hospitalization

  Measured during the index hospitalization.

• Duration of Surgery

  Recorded intraoperatively.

• Intraoperative Blood Loss

  Assessed during the surgical procedure.

• Rate of Perioperative Complications

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

Study Arms (1)

Cervical Spinal Stenosis Cases

Patients 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.

Procedure: Posterior Uniportal Endoscopic Cervical Decompression

Interventions

Posterior Uniportal Endoscopic Cervical Decompression PROCEDURE

Posterior Uniportal Endoscopic Cervical Decompression

Cervical Spinal Stenosis Cases

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Ángeles Tijuana: collaborator
• Hospital Zambrano Hellion TecSalud, Mexico: collaborator
• TecSalud Investigación Clínica: lead
• Tecnologico de Monterrey: collaborator
• Centro Medico Nacional Siglo XXI IMSS: collaborator
• TecSalud: collaborator

Study Sites (1)

Hospital Zambrano Hellion, TecSalud

San Pedro Garza García, Nuevo León, 66278, Mexico

RECRUITING

Related Publications (3)

• 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.

  PMID: 28739520 BACKGROUND

• 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.

  PMID: 35964065 BACKGROUND

• 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.

  PMID: 31268958 BACKGROUND

Study Officials

• Mario Benvenutti Regato, MD

  TecSalud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

► Mario Benvenutti Regato, MD

CONTACT

(+52) 81 8888 0675; mbenreg@tec.mx

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: February 18, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)