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Multicenter, randomized, single-blind, positive parallel controlled clinical trial to evaluate the effectiveness and safety of porous (metal) mesh fusion cages for spinal (cervical) fusion

Multicenter, randomized, single-blind, positive parallel controlled clinical trial to evaluate the effectiveness and safety of porous (metal) mesh fusion cages for spinal (cervical) fusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034970
Enrollment
Unknown
Registered
2020-07-26
Start date
2018-05-15
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

Diseases requiring cervical fusion

Interventions

experiment group:porous (metal) mesh fusion cages
control group:mesh vertebral fusion cage

Sponsors

The First Affiliated Hospital of University of South China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years old; (2) Patients who need cervical fusion, cervical degeneration, cervical fracture, cervical tuberculosis, etc. (3) Subjects whose estimated survival time is greater than 6 months; (4) Voluntarily participate in the study and sign the informed consent form of the subject.

Exclusion criteria

Exclusion criteria: (1) Obese patients (BMI >=28.0kg / m2) that will cause the implant to fail to fix or the implant itself will be damaged due to overload; (2) Spinal tumors, including metastatic tumors; (3) Patients with cervical deformity; (4) Patients with a history of metal allergy; (5) Women during pregnancy or lactation; (6) Patients with obvious local or systemic severe infection, such as osteomyelitis; (7) Severe systemic diseases such as liver, kidney, brain, cardiovascular, respiratory and endocrine system, which cannot bear the operation; (8) Severe osteoporosis (T value =40 cigarettes per day; (12) Long-term use of drugs that affect bone and soft tissue healing (such as chemotherapy drugs, corticosteroids, except methylprednisolone) (for continuous use for more than 3 months); (13) Other conditions judged by the researcher as unsuitable for selection; (14) Subjects who participated in other clinical trials within 3 months before the start of this trial.

Design outcomes

Primary

MeasureTime frame
Bone graft fusion;

Secondary

MeasureTime frame
JOA score and improvement rate;Height of anterior and posterior edge of fusion segment;VAS score;

Countries

China

Contacts

Public ContactYan Yiguo

The First Affiliated Hospital of University of South China

yan_yiguo@qq.com+86 18907343339

Outcome results

None listed

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