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A prospective randomized controlled study of collagen biomembrane combined with glucocorticoid to improve dysphagia after anterior cervical surgery

A prospective randomized controlled study of collagen biomembrane combined with glucocorticoid to improve dysphagia after anterior cervical surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069725
Enrollment
Unknown
Registered
2023-03-24
Start date
2023-03-24
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Cervical degenerative disease

Interventions

A:Collagen biomembrane+Glucocorticoid
B:Collagen biomembrane only
C:blank

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-65; (2) According to the clinical symptoms, physical signs and imaging findings (satisfying any of the following conditions: nucleus pulposus prolapse; obvious osteophyte formation; intervertebral height loss), patients with cervical spondylosis were diagnosed clearly; (3) Those who are ineffective or have progressive symptoms after standard conservative treatment, affecting daily life and work, and need to undergo anterior decompression surgery; (4) The surgical segment is between C3/4 and C6/7. (5) Be able to fully comply with this agreement psychologically and physically, and cooperate with the scheduled treatment plan, fill in the form, and follow up. (6) After the patient signs the informed consent, it means that the patient has known and agreed to carry out the relevant aspects of this study. The above inclusion standards are international common standards to ensure rationality and feasibility.

Exclusion criteria

Exclusion criteria: (1) Previous history of cervical surgery. (2) Ossification of posterior longitudinal ligament or stenosis of cervical spinal canal, spinal fracture, severe osteoporosis or history of bone metabolic disease. (3) Local infection and ulceration of neck skin, systemic inflammatory disease, uncontrolled diabetes, malignant tumor, active hepatitis, etc. (4) People with mental illness or mental disorder. (5) The general condition is poor, and important organs are suffering from serious diseases and cannot tolerate surgery. (6) Known to suffer from infectious diseases such as AIDS, syphilis, etc. (7) Suffer from autoimmune diseases. (8) He has received daily immunosuppressive therapy for more than 1 month in the past 12 months. (9) Allergic to implant materials (PPE K or titanium alloy) or experimental drugs. (10) Severe obesity, drug abuse history. (11) Pregnancy planner during pregnancy or study. (12) He is participating in other studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Baza score;Swallowing-Quality of Life;

Secondary

MeasureTime frame
Prevertebral soft tissue thickness;fusion rate;

Countries

China

Contacts

Public ContactHao Liu

West China Hospital, Sichuan University

dr_liuhao6304@126.com17713565390

Outcome results

None listed

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