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Anterior Cervical Discectomy and Fusion with Preemptive Closure of the Anterior Longitudinal Ligament for the Prevention of Dysphagia: A Prospective Randomized Controlled Study Protocol

Anterior Cervical Discectomy and Fusion with Preemptive Closure of the Anterior Longitudinal Ligament for the Prevention of Dysphagia: A Prospective Randomized Controlled Study Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077852
Enrollment
Unknown
Registered
2023-11-21
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

cervical spondylosis

Interventions

Group A:In the anterior cervical approach, the incision was closed routinely without suturing the anterior longitudinal ligament
Group B:In the anterior cervical approach, closure included suturing of the anterior longitudinal ligament
Group C:In the anterior cervical approach, closure involved suturing of the anterior longitudinal ligament and placement of a collagen biomembrane

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18 and 65 years old;(2) Patients diagnosed with cervical spondylopathy, either radiculopathy or myelopathy, based on clear clinical symptoms, physical signs, and imaging findings;(3) Individuals who have undergone standard conservative treatments without improvement or with progressively worsening symptoms, significantly impacting daily life and work, necessitating anterior decompression surgery;(4) Candidates for single-segment fusion surgery or artificial cervical disc replacement surgery with the operative level located between C3 and C7;(5) Willing and able to fully comply with this protocol both psychologically and physiologically, cooperate with the prescribed treatment plan, complete the required forms, and participate in follow-up assessments;(6) Patient's signature on the informed consent indicates their awareness and agreement to the relevant aspects of this study. The inclusion criteria adhere to internationally recognized standards, ensuring reasonability and feasibility.

Exclusion criteria

Exclusion criteria: (1) History of previous cervical spine surgery or adjacent segment bony fusion;(2) Cervical canal stenosis, spinal fractures, severe osteoporosis, or a history of metabolic bone diseases;(3) Local skin infection or breakdown in the cervical region, systemic inflammatory diseases, rheumatoid arthritis, uncontrolled diabetes, malignant tumors, active hepatitis, etc.;(4) Individuals with psychiatric disorders or psychological impediments;(5) Poor overall health, severe diseases affecting vital organs, or inability to tolerate surgery;(6) Known infectious diseases such as HIV/AIDS, syphilis, etc.;(7) Daily immunosuppressive therapy for more than one month within the past 12 months;(8) Allergy to implant materials or hemostatic agents;(9) Severe obesity, history of substance abuse;(10) Pregnancy or planning pregnancy during the study period;(11) Requirement for combined anterior and posterior approach surgery;(12) Participation in other studies that could potentially affect the results of this research.

Design outcomes

Primary

MeasureTime frame
Bazaz Swallowing Function Score;

Secondary

MeasureTime frame
JOA score;NDI score;VAS score;Imaging Parameters;

Countries

China

Contacts

Public ContactHao Liu

West China Hospital, Sichuan University

dr_liuhao6304@126.com+86 189 8060 1369

Outcome results

None listed

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