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Efficacy and Safety of Osseous Decompression Combined with Dural Decompression versus Simple Osseous Decompression for Acute Severe Traumatic Spinal Cord Injury: A Prospective, Multicenter, Randomized Controlled Trial

Efficacy and Safety of Osseous Decompression Combined with Dural Decompression versus Simple Osseous Decompression for Acute Severe Traumatic Spinal Cord Injury: A Prospective, Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120384
Enrollment
Unknown
Registered
2026-03-13
Start date
2026-03-15
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Traumatic spinal cord injury

Interventions

Experimental group:Bony Deompression and Dural Decompression
Control group:Bony decompression

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 - 80 years old, gender not restricted; 2. After clinical assessment including medical history, physical examination, and auxiliary tests, diagnosed as patients with cervical or thoracic (C2-T12) spinal cord injury caused by trauma; 3. According to the International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI), classified as grades A, B, or C based on the ASIA impairment scale (AIS); 4. Surgery was performed within 72 hours after traumatic spinal cord injury; 5. Preoperative MRI T2-weighted sequence indicated that there was no cerebrospinal fluid signal between the spinal cord and the dura mater in at least one segment; 6. Generally in good health condition, with an expected lifespan of >= 12 months; 7. The subjects voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with follow-up.

Exclusion criteria

Exclusion criteria: 1. Combined with other severe injuries (such as brain injury, liver and spleen rupture, etc.) or underlying diseases unsuitable for surgical treatment (judged by the principal investigator); 2. Transverse spinal cord injury; 3. Spinal cord gunshot or sharp instrument injury; 4. Rupture of the dura mater caused by traumatic spinal cord injury; 5. Other diseases (including mental disorders) that may impede accurate medical and neurological assessment (judged by the principal investigator)

Design outcomes

Primary

MeasureTime frame
The change value of the motor score of the American Spinal Injury Association;

Secondary

MeasureTime frame
American Spinal Injury Association Motor Function Score;American Spinal Injury Association Sensory Score;American Spinal Injury Association Classification;Spinal Cord Injury Walking Index;Spinal Cord Injury Independence Scale Score;Quality of Life Scale Score;Degree of pain;Neurogenic bladder symptom score;Neurogenic intestinal dysfunction score;Adverse event;

Countries

China

Contacts

Public ContactWanru Duan

Capital Medical University Xuanwu Hospital

duanwanru@xwhosp.org+86 10 83198899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026