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A prospective randomized controlled study on the clinical and radiological evaluation of ACDF combined with uncinatectomy in patients with cervical spondylotic radiculopathy

A prospective randomized controlled study on the clinical and radiological evaluation of ACDF combined with uncinatectomy in patients with cervical spondylotic radiculopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075855
Enrollment
Unknown
Registered
2023-09-18
Start date
2023-09-18
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Cervical degenerative disease

Interventions

Group A:Partial Uncinatectomy During ACDF for Neural Foraminal Decompression
Group B:Expanding Uncinatectomy During ACDF for Neural Foraminal Decompression
Group C:Not Performing Neural Foraminal Decompression During ACDF

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The age is 18~65 years old; 2. Patients with a confirmed diagnosis of single-level cervical spondylotic radiculopathy based on clinical symptoms, physical signs, and imaging findings; 3. After standardized conservative treatment, the symptoms are ineffective or gradually aggravated, which affects daily life and work and requires anterior decompression surgery; 4. The surgical segment is between C3/4 and C6/7; 5. Be able to fully abide by this agreement psychologically and physically, and cooperate with the scheduled treatment plan and fill in the form, and cooperate with the follow-up; 6. After the informed consent is signed by the patient, it means that the patient already knows and agrees to carry out the relevant aspects of this study. The above standards are international standards, which are reasonable and feasible.

Exclusion criteria

Exclusion criteria: 1. Previous history of cervical spine surgery; 2. Posterior longitudinal ligament ossification or cervical spinal stenosis, spinal fracture, severe osteoporosis or a history of bone metabolic disease; 3. Local infection and ulceration of neck skin, systemic inflammatory diseases, uncontrolled diabetes, malignant tumors, active hepatitis, etc.; 4. People with mental illness or mental disorder; 5. The general condition is poor, and the vital organs suffer from serious diseases and cannot tolerate surgery; 6. Known to have infectious diseases such as AIDS, syphilis, etc.; 7. Suffering from autoimmune diseases; 8. Received daily immunosuppressant therapy for more than 1 month in the past 12 months; 9. Hypersensitivity to implant materials (PPEK or titanium alloy) or experimental drugs; 10. Severe obesity, history of drug abuse; 11. Those who are pregnant or have a pregnancy plan during the study; 12. Participating in other studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Cervical Spine Disability Index;

Secondary

MeasureTime frame
Visual Analog Score;Therapeutic Index of the Japanese Orthopaedic Association;The Area and Volume of Uncovertebral Joint Resection;Other imaging parameters;

Countries

China

Contacts

Public ContactBeiyu Wang

West China Hospital, Sichuan University

dove-baker@163.com+86 189 8060 2286

Outcome results

None listed

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