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A prospective randomized controlled study on the clinical efficacy of two nail and four nail zero notch interbody fusion cage and uncinate vertebral joint fusion cage in anterior cervical discectomy and fusion

A prospective randomized controlled study on the clinical efficacy of two nail and four nail zero notch interbody fusion cage and uncinate vertebral joint fusion cage in anterior cervical discectomy and fusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057983
Enrollment
Unknown
Registered
2022-03-24
Start date
2022-05-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

Cervical degenerative disease

Interventions

A:Useing two screw fusion device (zero-p VA)
B:Useing four screw fusion device (Zero-p)

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 65 years old; 2. Patients with single-segment cervical spondylosis diagnosed according to clinical symptoms, signs, and imaging findings; 3. After standardized conservative treatment, it is ineffective or the symptoms are aggravated, which affects daily life and work, and requires anterior decompression surgery; 4. The operative segment was located between C3/4 and C6/7; 5. Be able to fully comply with this agreement psychologically and physiologically, cooperate with the scheduled treatment plan, fill in forms, and cooperate with the follow-up; 6. After the patient signs the informed consent, it means that the patient has known and agreed to the implementation of relevant aspects of this study. The above inclusion criteria are general international standards to ensure that they are reasonable and feasible.

Exclusion criteria

Exclusion criteria: 1. Previous history of cervical surgery and adjacent segmental bone fusion; 2. Ossification of posterior longitudinal ligament or cervical spinal stenosis, spinal fracture, severe osteoporosis or history of bone metabolic diseases; 3. Local skin infection, ulceration, systemic inflammatory disease, rheumatoid arthritis, non controlled diabetes, malignant tumor, active hepatitis and so on; 4. Have mental illness or mental disorder; 5. Poor general condition, serious diseases of important organs and can not tolerate surgery; 6. Known infectious diseases such as AIDS and syphilis; 7. In the past 12 months, immunosuppressive therapy was used for more than 1 months in the past 12 month; 8. Allergy to implant materials (PPEK or titanium alloy); 9. Severe obesity, history of drug abuse; 10. Pregnancy planners during pregnancy or research period; 11. Participating in other studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Fusion rate;

Secondary

MeasureTime frame
Japanese orthopaedic association, JOA;Visual analogue scale, VAS;

Countries

China

Contacts

Public ContactHao Liu

West China Hospital, Sichuan University

dr_liuhao6304@126.com+86 17713565390

Outcome results

None listed

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