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Clinical trial of thoracolumbar posterior internal fixation system

Clinical trial of thoracolumbar posterior internal fixation system

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095516
Enrollment
Unknown
Registered
2025-01-08
Start date
2025-01-13
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Diseases requiring thoracolumbar internal fixation

Interventions

Experimental group:Using"NOAH 4.5 CoCrMo Posterior Thoracolumbar Spinal System"for thoracolumbar internal fixation surgery
Control group:Using"LEO Thoracolumbar Posterior Screw Rod System"for thoracolumbar internal fixation surgery

Sponsors

Chinese PLA General Hosptial
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 75 years old and below (including 75 years old); 2. Disease requirements: patients with spinal degenerative diseases, spinal fractures, scoliosis, etc., who need thoracolumbar internal fixation; 3. Voluntarily participate in this trial, expected to be able to complete the trial process, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The patient is mentally incapable or unable to understand the requirements to participate in the study; 2. Projected non-adherence; 3. Known patient has a history of allergy to one or more implanted materials; 4. Presence of active infection lesions locally or systemically; 5. Pregnant or lactating women; 6. The subject has other diseases that restrict the participant from participating in the study, cannot comply with the follow-up or affect the scientific integrity of the study; 7. Patients with severe osteoporosis who are clinically judged to be unsuitable for surgery; 8. Spinal tumors, including metastases; 9. The researcher deems it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Effective rate;

Secondary

MeasureTime frame
Fusion rate;JOA score improvement rate;The MOS item short from health survey, SF-36;Scoliosis Research Society, SRS-22;Compatibility of surgical instrument;

Countries

China

Contacts

Public ContactKeya Mao

General Hospital of the Chinese people's Liberation Army

maokeya@sina.com+86 10 6693 8402

Outcome results

None listed

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