Acute spinal cord injury
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Aged 20-70 years old, male or female; 2) Diagnosed with acute spinal cord injury (ASIA grade A-C) (thoracic) requiring surgical laminectomy for decompression; 3) Patients who have been determined by the investigator to meet the illumination fiber in the implant's clinical verification; 4) The patient fully understands the contents and requirements of the clinical verification and can complete the follow-up according to the time specified in the protocol; 5) Voluntary participation in clinical verification and signing of informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients have a systemic infection or localized infection at the target surgical site; 2) Patients have more than 2 segments of spinal cord injury and all vital signs are unstable; 3) Patients with malignant tumors are not involved in the target surgical site; 4) The patient's life expectancy is less than one year; 5) Pregnancy or lactation women; 6) The patient is too obese with BMI =40; 7) patients with other systemic diseases who are taking corticosteroids, or patients with growth factors, or long-term use of non-steroidal anti-inflammatory drugs; 8) The patient has a history of endocrine diseases (such as drugs that are difficult to control diabetes, metabolic bone diseases, etc.) or autoimmune diseases (such as multiple sclerosis) that affect the process of bone metabolism; 9) There is alcohol abuse within a year (average daily alcohol consumption >40g, equivalent to 50ml alcohol 100ml, or smoking =40 cigarettes/day, or drug abusers); 10) Are participating in other drug or device clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI;ASIA Motor and Sensory Function Rating;EMG;Biochemical indicators; | — |
Countries
China
Contacts
Department of Orthopaedics, Xijing Hospital, Fourth Military Medical University