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Application of Microscopic Assisted Small Incision in Single Segment Anterior Cervical Surgery for Cervical Spondylosis: A Prospective Randomized Controlled Trial Study Protocol

Application of Microscopic Assisted Small Incision in Single Segment Anterior Cervical Surgery for Cervical Spondylosis: A Prospective Randomized Controlled Trial Study Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095902
Enrollment
Unknown
Registered
2025-01-15
Start date
2025-01-25
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical spondylosis

Interventions

Experimental group (Group A): Microscopic assisted small incision during single segment anterior cervical surgery. :Microscopic assisted small incision during single segment anterior cervical surgery
Control group (Group B): Traditional incision assisted by microscope during single segment anterior cervical surgery.:Traditional incision assisted by microscope during single segment anterior cervica

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients with radiculopathy or myelopathy caused by single-level cervical disc disease, with magnetic resonance imaging results supporting the diagnosis, who have failed to respond to standard conservative treatment or have progressive symptoms that affect daily life and work, and require anterior decompression surgery; (2) Patients over 18 years old with surgical levels located between C3 and C7; (3) Patients with detailed preoperative and postoperative anterior-posterior and lateral X-ray films and clinical data; (4) Patients who are mentally and physically capable of fully complying with this agreement, following the prescribed treatment plan, completing forms, and participating in follow-up for at least one year; (5) Patient's signing of the informed consent implies that they have been informed of and agree to the relevant aspects of this study being implemented and conducted.

Exclusion criteria

Exclusion criteria: (1) Patients with preoperative dysphagia; (2) Patients with psychological disorders such as mania, severe depression, or a history of central nervous system diseases including traumatic brain injury, stroke, etc.; (3) Patients with a history of previous cervical spine surgery, adjacent segment bony fusion, esophageal diseases, revision surgeries, or neck surgeries; (4) Patients with local infection or ulceration of the neck skin, pathological fractures of the vertebrae, spinal deformities, ossification of the posterior longitudinal ligament (OPLL), rheumatoid arthritis, ankylosing spondylitis, developmental stenosis, and local or systemic infections; (5) Patients with poor overall health status, severe diseases of vital organs, or intolerance to surgery; (6) Pregnant women or those planning pregnancy during the study period; (7) Patients currently participating in other studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Incision dynamic evaluation;

Secondary

MeasureTime frame
Neck incision length;Numbness range of neck incision;Dysphagia;Dysphonia;Operation effect;Patient satisfaction index;Prevalence of complications and patient-reported outcome measures (PROMs), including the Japanese Orthopaedic Association (JOA) score, Neck Disability Index (NDI), and visual analog scale (VAS) scores for arm and neck pain.;

Countries

China

Contacts

Public ContactWang Beiyu

No. 37 Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

zhaoxiaoqiang@stu.scu.edu.cn+86 177 9414 5951

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026