Diseases requiring lumbar lateral approach surgery
Conditions
Interventions
Experimental group:Using"Uni-L Standalone Lumbar Interbody Fusion Cage"for Lumbar lateral approach surgery
Control group:Using"Gemini Medical Cage System"for Lumbar lateral approach surgery
Sponsors
General Hospital of the Chinese people's Liberation Army
Eligibility
Sex/Gender
All
Age
No minimum to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age <= 75 years; (2) Patients with intervertebral disc herniation, intervertebral disc degeneration, narrowing of intervertebral space, slippage, instability, and scoliosis, etc; (3) Patients voluntarily participate in this trial and are expected to complete the trial process and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Severe systemic or local infection; (2) Any psychiatric or neuromuscular disorders that may result in an unacceptable risk of fixation failure or complications during postoperative care; (3) Pregnancy; (4) Clear or suspected allergy to metals, polymer materials, or foreign objects used in the product; (5) Patients with severe osteoporosis who are clinically deemed unsuitable for surgery; (6) Systemic or metabolic diseases; (7) The patient is incapable or unable to understand the requirements for participating research mentally; (8) Spinal tumors, including metastases; (9) Patients whom the investigators deemed inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic indexes;JOA score improvement rate;Visual Analogue Scale;The MOS item short from health survey, SF-36;Compatibility of surgical instrument; | — |
Countries
China
Contacts
Public ContactKeya Mao
General Hospital of the Chinese people's Liberation Army
Outcome results
None listed