L5/S1 lumbar disc herniation
Conditions
Interventions
Self-stabilizing intervertebral fusion device treatment group:Anterior lumbar fusion with custom-made self-stabilizing interbody fusion devices
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 to 70 years (inclusive of 18 and 70 years old), regardless of gender,; 2.Diagnosed with L5-S1 segment lumbar disc herniation; 3.Exhibiting symptoms such as low back pain or lower limb numbness and pain; 4.Have not responded well to 3 months of conservative treatment prior to surgery; 5.Have not participated in other clinical trials within the last 3 months; 6.Patients must be willing to undergo anterior lumbar interbody fusion (ALIF) and understand the associated surgical risks and potential outcomes; 7.They should be capable of effective communication and follow-up with the research team during the study period; 8.Participants must have familial support to provide necessary care during the surgical and rehabilitation period; 9.A preoperative lifestyle assessment must indicate that the participants can adhere to postoperative rehabilitation plans and restrictions; 10.Participants must agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with severe osteoporosis (bone density T = 40); 8.Pregnant patients; 9.Patients who have previously undergone fusion surgery at the treated intervertebral segment; 10.Any medical or surgical conditions that may affect the benefits of spinal implant surgery, such as a history of severe metabolic diseases, immune system diseases, hematological disorders, and malignancies; 11.Other conditions deemed unsuitable for inclusion by the researchers; 12.Patients with severe systemic diseases (e.g., heart disease, lung disease) that may affect the safety of surgery or anesthesia; 13.A history of mental illness that may affect understanding or compliance with the treatment plan; 14.A recent history (e.g., within the past 12 months) of alcohol abuse or drug abuse that may affect postoperative recovery; 15.A history of allergy to the anesthetic agents used, which may increase anesthesia risk; 16.Endocrine diseases that affect bone healing, such as uncontrolled diabetes or hyperparathyroidism; 17.The presence of chronic infections, skin infections, or other conditions that may lead to postoperative complications; 18.Patients with a recent history (e.g., within the past year) of spinal surgery; 19.Any circumstances that would make long-term follow-up after surgery difficult, such as plans to relocate to another area during the study period. 20.Do not agree to participate in the study or refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging fusion success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate of intervertebral space height at the surgical segment.;VAS Score;SF-12 Score;Safety;JOA Score; | — |
Countries
China
Contacts
Public ContactWanru Duan
Xuanwu Hospital, Capital Medical University
Outcome results
None listed