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Clinical Evaluation of Zero-Profile Cage in Anterior Cervical Discectomy and Fusion(ACDF) for Cervical Disc Herniation: A Non-Inferiority Multicenter Randomized Controlled Trial(RCT)

Clinical Evaluation of Zero-Profile Cage in Anterior Cervical Discectomy and Fusion(ACDF) for Cervical Disc Herniation: A Non-Inferiority Multicenter Randomized Controlled Trial(RCT)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047679
Enrollment
Unknown
Registered
2021-06-21
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-02-28

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

Conditions

Cervical Disc Herniation

Interventions

control group:ACDF with conventional plating
experimental group:ACDF with zero-profile

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 80 years; 2. Preoperative MRI and CT confirmed signs of cervical disc herniation compressing the nerve root or spinal cord; 3. typical manifestations of cervical spondylosis include neck and shoulder pain, numbness of both upper limbs, weakening of grip strength, and feeling of stepping on cotton; 4. The symptoms were not significantly relieved or even aggravated after 3 months of formal conservative treatment; 5. No absolute surgical contraindication; 6. Informed consent of patients.

Exclusion criteria

Exclusion criteria: 1. Pregnant women or lactating women with high ß-HCG were screened; 2. A history of cervical surgery; 3. Congenital spinal stenosis or cervical deformity; 4. Patients with preoperative dysphagia; 5. Infected and tumor patients; 6. Can not follow the protocol for follow-up, or the investigator believes that the subject's participation in the study will increase the risk; 7. Unable to provide written informed consent, or unable to follow the test protocol; 8. Expected survival time less than 2 years; 9. Those who plan to immigrate within one year or have language communication difficulties; 10. Other serious physical or mental diseases are not suitable for surgery; 11. Participating in other clinical trials; 12. Patients with rheumatic immune diseases that may cause similar symptoms.

Design outcomes

Primary

MeasureTime frame
Bone fusion rate;Adjacent segment degeneration;C2-C7 Cobb Angle;Complications;

Secondary

MeasureTime frame
Numeric rating scale;Japanese orthopaedic association, JOA;Dysphagia;

Countries

China

Contacts

Public ContactChen Chunmei

Fujian Medical University Union Hospital

cmchen2009@sina.com+86 13509339040

Outcome results

None listed

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