lumbar spine disease
Conditions
Interventions
experimental group:The experimental group used peek fusion device + autogenous bone + natural bone
control group:The experimental group used peek fusion device + autogenous bone +allogeneic bone
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Voluntary participation and signing of informed consent; (2) Patients who need spinal fusion according to the investigator's assessment; (3) Aged 18 to 75 years old, male or female; (4) The spinal fusion level <=two segments (i.e., one or two segments); (5) Can cooperate with the test protocol and receive regular postoperative visits.
Exclusion criteria
Exclusion criteria: (1) Subjects who do not require or are not suitable for spinal fusion surgery by preoperative examination or intraoperative exploration; (2) Patients with severe systemic disease (determined by the investigator); (3) Patients with a history of spinal surgery; (4) Subjects with more than two levels of spinal fusion; (5) Subjects with local infection at the proposed surgical site; (6) Subjects with severe trauma that may cause infection; (7) Subjects with severe coagulation abnormalities within 3 months before the trial (determined by the investigator); (8) Subjects who received radiation therapy, chemotherapy, immunosuppression or systemic glucocorticoids within 6 months before the trial; (9) Overweight (body mass index [BMI] > 28); (10) Subjects with other contraindications for spinal fusion; (11) Patients with stroke and dementia; (12) Inflammatory bone disease, such as osteomyelitis; (13) Patients with malignant tumorsOr patients with a history of malignancy; (14) Pregnant or lactating women; (15) Other severe degenerative diseases (except degenerative disc disease); (16) Previous diagnosis of Paget's disease of bone, osteomalacia, or any other endocrine or metabolic bone disease that affects bone formation; (17) Subjects who are unwilling to receive blood products; (18) Subjects with scoliosis >=20 degree; (19) Subjects with kyphosis >=20 degree, more than three degrees of spondylolisthesis; (20) Subjects who cannot be enrolled in the opinion of other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate;Intervertebral space height; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intervertebral space height;VAS score;ODI score;SF-36 score;Time of surgery;peroperative blood loss; | — |
Countries
China
Contacts
Public ContactYong Hai
Beijing Chaoyang Hospital, Capital Medical University ,Beijing, China.
Outcome results
None listed