Lumbar degenerative diseases include lumbar disk herniation, degenerative lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, and discogenic low back pain.
Conditions
Interventions
Additive-manufactured porous tantalum cage group:Intraoperative implantation of the additive-manufactured porous tantalum cage(s)
PEEK cage group:Intraoperative implantation of the PEEK cage(s)
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The subject voluntarily signs the informed consent form; 2.The subject is aged 45-75 years (inclusive), with no gender restriction; 3.The subject should have lumbar degenerative disease, including lumbar disc herniation, degenerative lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, and discogenic low back pain;
Exclusion criteria
Exclusion criteria: 1.Active local infection in the surgical area or adjacent regions; 2.Active systemic infection and/or disease; 3.Severe osteoporosis or insufficient bone density, as determined by the physician, that precludes surgery or implantation of devices; 4.Conditions outside the scope of the indications; 5.Previous surgery using the same surgical approach, or prior fusion at the treated segment; 6.Presence of metastatic tumors in the vertebrae adjacent to the implant; 7.Known or suspected metal allergy; 8.Endocrine or metabolic disorders that may affect bone formation (e.g., Paget's disease, renal osteodystrophy, hypothyroidism); 9.Systemic diseases requiring long-term treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids; 10.Severe mental disorders or diseases that would affect the patient's ability to remember and follow pre- and postoperative instructions (e.g., treated psychiatric/psychosocial disorders, dementia, Alzheimer's disease, traumatic brain injury, amnesia, etc.); 11.Neurological or muscular disorders that would pose an unacceptable risk of implant instability, fixation failure, or postoperative care complications (e.g., spina bifida, cerebral palsy, multiple sclerosis); 12.Patients unwilling to comply with postoperative instructions, especially those engaged in sports or occupational activities; 13.Morbid obesity; 14.Symptomatic cardiac disease; 15.Severe anatomical deformity; 16.Participation in another clinical trial within one month prior to enrollment in this study; 17.Alcohol or drug abuse, or substance dependency; 18.Patients who are mentally incapacitated or unable to understand the requirements of study participation and are unlikely to cooperate; 19.Other comorbidities that would restrict the patient's participation in the study, prevent compliance with follow-up, or affect the scientific integrity of the study; 20.Other situations in which the investigator deems the patient unsuitable for participation in this study (e.g., anticipated poor compliance, unrealistic treatment expectations, or significant emotional issues);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subsidence;JOA?ODI?VAS?SF-36?Prolo?DRI?RMDQ scores;Stable;Wound healing, infection; | — |
Countries
China
Contacts
Public ContactRuida Xu
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed