Degenerative diseases of the spine
Conditions
Interventions
Experimental group:Surgical implantation of the experimental group of instruments
Control group:Surgical implantation of control group instruments
Sponsors
The First Affiliated Hospital of the Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects participating in this clinical validation must meet all of the following criteria: 1.Subjects are aged 18-75 years old (including 18 years old and 75 years old), and gender is not limited; 2.Intervertebral disc herniation and/or vertebral segment instability due to intervertebral disc degeneration, requiring intervertebral fusion surgery subjects; 3.Subjects are cervical (C2/3-C7/T1) or lumbosacral (T12/L1-L5/S1), one or two Segmental fusion of the intervertebral body; 4.Subjects have been treated conservatively for at least 4-6 weeks without surgery (emergencies that are considered by the investigator to be eligible for surgical indications except for patients); 5.Those who have not participated in other clinical trials within 3 months; 6.Voluntary test and signed informed consent.
Exclusion criteria
Exclusion criteria: Subjects participating in this clinical validation who meet any of the following criteria are not eligible for enrollment: 1. Patients who are mentally incapable or unable to understand the requirements for participating in the study, such as unable to formulate, read and understand the questions in the subject's subjective questionnaire specified in the study protocol, and unable to provide feedback information in appropriate language; 2.Any person who is unwilling to comply with the postoperative instructions or medical advice; 3.Patients with any medical or surgical diseases that may affect the benefit of spinal implant surgery, such as those with a history of severe metabolic system diseases, immune system diseases, hematologic diseases, and malignant tumors, etc.; 4.Those with serious heart, liver, lung, kidney and other important organ diseases (judged by the investigator); 5.Patients with obvious abnormalities in body temperature, blood sedimentation rate, and white blood cell count for which the cause cannot be determined; 6.Those who do not have sufficient soft tissue coverage at any surgical site; 7.Congenital or acquired increased bone fragility, or severe calcification problems; 8.Those who have infection involving the surgical site or local inflammation; 9.Those with a history of mental illness, drug abuse or alcoholism; 10.pathologically obese patients (body mass index [BMI]>=40); 11.Pregnant patients; 12.Patients with rapidly progressive arthropathy, osteomalacia, bone resorption and severe osteoporosis (T<-3.5); 13.Those who are suspected or confirmed to be allergic or intolerant to foreign bodies (metal materials); 14.Those who have previously undergone fusion surgery for the intervertebral segment to be treated; 15.Patients with immature bones and are developing; 16.Those who take drugs that affect bone and soft tissue healing for a long time (such as chemotherapy drugs, corticosteroids, etc.); 17.Those who are undergoing radiotherapy; 18.Those who use growth factors or long-term use of sedative-hypnotic drugs or non-steroidal anti-inflammatory drugs (continuous use for more than 3 months); 19.The expected life expectancy of the subject is less than half a year; 20.Other circumstances judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate of JOA functional scores;Rate of improvement in VAS pain score;Intervertebral space height; | — |
Countries
China
Contacts
Public ContactGuo Zheng
The First Affiliated Hospital of the Air Force Military Medical University
Outcome results
None listed