Musculoskeletal system or connective tissue diseases
Conditions
Interventions
experimental group:Traditional OLIF surgery + Spinal intervertebral fusion device with bone repair material composite gel patch.
control group:Traditional OLIF surgery + ordinary spinal interbody fusion device.
Sponsors
The Affiliated Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
10 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18years <= age <= 80 years. 2. The patient is currently suffering from lumbar spinal stenosis (a clinical syndrome resulting from compression of the nerve roots or cauda equina due to factors such as lumbar disc herniation or facet joint hypertrophy, manifested as low back pain, radiating leg pain, lower limb numbness, weakness, intermittent claudication, and even bowel or bladder dysfunction). 3. Lumbar spinal stenosis is diagnosed by lumbar imaging examinations (plain radiograph, CT, and MRI), with compression of neural tissues (spinal cord or nerve roots) caused by a herniated disc or hypertrophic facet joints, or compression of neural tissues due to stenosis of the nerve root exit. 4. Presence of obvious clinical symptoms of lumbar spinal stenosis, including: low back pain, lower limb numbness and pain, intermittent claudication; physical examination findings such as limited lumbar extension, positive or negative straight leg raise test, abnormal knee or Achilles tendon reflexes, and other abnormal signs. 5. No significant improvement of symptoms after more than 6 months of conservative treatment, which severely affects the patient's quality of life. 6. Voluntary participation in this study and signing of the informed consent. If the subject is unable to read and sign the informed consent due to lack of capacity (e.g., incompetent subjects), their legal guardian shall act as a proxy for the informed consent process and sign the informed consent. If the subject is unable to read the informed consent (e.g., illiterate subjects), a witness shall witness the informed consent process and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with severe primary diseases of the cardiovascular, hepatic, renal, or hematopoietic systems, as well as malignant tumors. 2. Patients with congenital lumbar deformities, or a history of infection, tumor, or trauma that has led to significant morphological abnormalities of the lumbar spine. 3. Presence of compressive diseases of the spine other than the lumbar spine, such as cervical disc degenerative disease, cervical hyperextension injury, ossification of the posterior longitudinal ligament of the cervical spine, ossification of the posterior longitudinal ligament of the thoracic spine, or ossification of the ligamentum flavum of the thoracic spine. 4. Presence of other diseases that affect neurological function and may interfere with postoperative outcomes, such as piriformis syndrome, sciatic nerve injury, poliomyelitis, or Guillain-Barré syndrome. 5. Vulnerable populations other than the elderly/illiterate, including patients with mental disorders, cognitive impairment, critically ill patients, and pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative interbody fusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| JOA neurological function score;VAS low back pain score; | — |
Countries
China
Contacts
Public ContactShunwu Fan
Zhejiang University School of Medicine Affiliated Sir Run Run Shaw Hospital
Outcome results
None listed