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A prospective randomized controlled study on the clinical outcome of zero-profile device in anterior cervical discectomy and fusion

A prospective randomized controlled study on the clinical outcome of zero-profile device in anterior cervical discectomy and fusion

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045049
Enrollment
Unknown
Registered
2021-04-04
Start date
2021-04-15
Completion date
Unknown
Last updated
2021-11-08

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 group:Zero-notch interbody fusion cage VA
B group:Kangsheng cervical interbody fusion cage
C group:Zero-notch interbody fusion cage

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 single-segment cervical spondylopathy diagnosed based on clinical symptoms, signs and imaging findings; 3.After standard conservative treatment, it is ineffective or the symptoms are progressively aggravated, which affects daily life and work, and requires anterior decompression surgery; 4.The surgical segment is located between C3/4~C6/7; 5.Be able to fully comply with this agreement psychologically and physically, and cooperate with the predetermined treatment plan, fill out the form, and cooperate with the 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 research.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
fusion rate;T1 slope;

Secondary

MeasureTime frame
C2-7 Cobb angle;Sagittal vertical axis;Japanese Orthopaedic Association Evaluation Treatment Score (Cervical Spine);Cervical spine dysfunction index;Visual analog scale;Summary of Health Survey;

Countries

China

Contacts

Public ContactLiu Hao

West China Hospital, Sichuan University

liuhao6304@163.com+86 18980601369

Outcome results

None listed

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