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A prospective randomized controlled trial of local use of glucocorticoids in anterior cervical discectomy and fusion to improve early postoperative neurological symptoms

A prospective randomized controlled trial of local use of glucocorticoids in anterior cervical discectomy and fusion to improve early postoperative neurological symptoms

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052157
Enrollment
Unknown
Registered
2021-10-20
Start date
2021-10-29
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Cervical degenerative disease

Interventions

Experimental group1:Intraoperative local use of glucocorticoids
Experimental group2:Postoperative intravenous glucocorticoids
Experimental group3:Intraoperative local + postoperative intravenous glucocorticoid
Control group:Intraoperative local + postoperative venous normal saline

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. According to clinical symptoms, signs and imaging manifestations (meet any one of the following: nucleus pulposus prolapse; obvious osteophyte formation; intervertebral height loss) diagnosed patients with cervical spondylosis; 3. After standardized conservative treatment, the symptoms are ineffective or the symptoms are progressively aggravated, which affects daily life and work, and requires anterior decompression surgery; 4. The operative segment is located between C3/4~C6/7; 5. NDI score greater than or equal to 30%; 6. Be able to fully comply with this agreement psychologically and physically, and cooperate with the scheduled treatment plan, fill in the form, and cooperate with follow-up visits; 7. 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.

Exclusion criteria

Exclusion criteria: 1. History of cervical spine surgery and bone fusion of adjacent segments; 2. Posterior longitudinal ligament ossification or cervical spinal stenosis, spinal fracture, severe osteoporosis or a history of bone metabolic disease; 3. Local infection and ulceration of neck skin, systemic inflammatory disease, uncontrolled diabetes, malignant tumor, active hepatitis, etc.; 4. Those with mental illness or mental disorder; 5. The general condition is poor, and the important organs suffer from serious diseases and cannot tolerate surgery; 6. Known to suffer from infectious diseases such as AIDS, syphilis, etc.; 7. Suffering from autoimmune diseases; 8. Have received daily immunosuppressive therapy for more than 1 month in the past 12 months; 9. Allergy to implant materials (PPEK or titanium alloy) or experimental drugs; 10. Severe obesity, history of drug abuse; 11. Those who have pregnancy plans during pregnancy or research; 12. Participating in other studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Visual Analog Score;

Secondary

MeasureTime frame
Cervical Spine Disability Index;Therapeutic Index of the Japanese Orthopaedic Association;health status questionnaire;Dysphagia classification;

Countries

China

Contacts

Public ContactLiu Hao

West China Hospital, Sichuan University

dr_liuhao6304@126.com+86 18980601369

Outcome results

None listed

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