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A prospective randomized controlled study of Anterior Cervical X-shaped corpectomy and fusion (ACXF) in the treatment of multi-level of cervical spondylosis

A prospective randomized controlled study of Anterior Cervical X-shaped corpectomy and fusion (ACXF) in the treatment of multi-level of cervical spondylosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067759
Enrollment
Unknown
Registered
2023-01-20
Start date
2023-01-31
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Cervical degenerative disease

Interventions

ACXF:Perform ACXF operation
ACCF:Perform ACCF operation

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. Patients with cervical spondylosis diagnosed clearly according to clinical symptoms, signs and imaging findings; 3. After standard conservative treatment, the patient is ineffective or the symptoms are gradually aggravated, affecting daily life and work, and needs to undergo ACCF or ACXF surgery; 4. The surgical segment is between C3/4 and C7T1; 5. Be able to fully comply with the contents of this study protocol psychologically and physiologically, and cooperate with the scheduled treatment plan, fill in the questionnaire 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 spine surgery and adjacent segmental bone fusion; 2. Cervical vertebra development deformity, spinal fracture, severe osteoporosis or history of bone metabolic disease; 3. Local infection and ulceration of neck skin, systemic inflammatory disease, rheumatoid arthritis, 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. He has received daily immunosuppressive therapy for more than 1 month in the past 12 months; 8. Allergic to implant materials (PPE K or titanium alloy); 9. Severe obesity, drug abuse history; 10. Pregnancy or pregnancy plan during the study period; 11. He is participating in other studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Japanese Orthopaedic Association Scores;Neck Disabilitv Index socre;visual analogue scale for arm and neck;

Secondary

MeasureTime frame
operation duration time;Bleeding durning surgery;fusion rate;Imaging complications;Total complications after cervical surgery;

Countries

China

Contacts

Public ContactChen Ding

West China Hospital, Sichuan University

dingchenspine@outlook.com+86 177 1356 5390

Outcome results

None listed

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