Symptomatic Degenerative Disease of The Lumbosacral Spine
Conditions
Interventions
Investigational Infuse 2.1 mg:Infuse 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
Investigational Infuse 4.2 mg:Infuse 4.2 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
Control: Local bone autograft:Local bone autograft and supplemented with cancellous allograft as needed
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has radiographic evidence (i.e. CT or MRI within 12 months of enrollment*) of degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by: a. History of radiating leg or buttock pain, paresthesia, numbness or weakness, or b. History of neurogenic claudication. *If a subject hasnt had a CT or MRI in the last 12 months, a CT/MRI will need to be obtained. 2. Has a history of low back pain. 3. Has radiographic evidence (i.e. CT orMRI within 12 months of enrollment*) of degenerative disease of the lumbosacral spine including at least one of the following: a. Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or b. Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or c. Recurrent disc herniation *If a subject hasnt had a CT or MRI in the last 12 months, a CT/MRI will need to be obtained. 4. Has preoperative Oswestry Disability Index score >= 40. 5. Has preoperative back pain score of >= 4 based on the Preoperative Back and Leg Pain Questionnaire. 6. Has preoperative leg pain score of >= 4 based on the Preoperative Back and Leg Pain Questionnaire. 7. Is at least 18 years of age and skeletally mature at the time of surgery. 8. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months. 9. Is willing and able to comply with the study plan and able to understand and sign the subject Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Prior surgical procedure at the involved or adjacent spinal levels (e.g. bony decompression, fusion, arthroplasty, and/or other non-fusion procedures). Prior discectomy at the target or adjacent levels is allowed. 2. Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level. 3. Planned use of an internal or external bone growth stimulator. 4. Lumbar scoliosis > 30 degrees. 5. Patients who had a previous diagnosis of osteoporosis with a T-score of -2.5 or below in the last 12 months existing together with a prevalent fragility fracture. If subject has a prevalent fragility fracture anda T-score hasnt been assessed in the last 12 months, a DEXA will need to be obtained. 6. Morbidly obese, as defined by a Body Mass Index (BMI) > 40. 7. Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin is allowed). 8. Overt or active bacterial infection, either local to surgical space or systemic. 9. Has undergone administration of any type of corticosteroid, anti-neoplastic, immunostimulating, or immunosuppressive agents, or medications known to interfere with the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment. (Use of NSAIDs, steroidal inhalers, and short-term steroidal use (e.g. Medrol Dosepak) is allowed. For this clinical study, short-term use is defined as <= two weeks.) 10. Co-morbidities, which in the investigators opinion, precludes the subject from being a surgical candidate. 11. Autoimmune disease, which in the investigators opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves disease, Hashimotos thyroiditis). 12. Any endocrine or metabolic disorder, which in the investigators opinion, is known to affect osteogenesis (e.g., Pagets disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta). 13. Known exposure to any recombinant proteins used for bone formation (e.g., Infuse? Bone Graft, OP-1 Putty, OP-1 Implant, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft). 14. Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or PEEK). 15. History of any allergy resulting in anaphylaxis. 16. Is a prisoner. 17. Is mentally incompetent. If questionable, obtain psychiatric consult. 18. Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment. 19. Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for 12 months following surgery. 20. A documented diagnosis of substance use disorder as defined by the DSM-5.22. 21. Pursuing workers compensation or active litigation for spinal fusion procedure. 22. Any condit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate non-inferiority in overall success at 24 months;Demonstrate superiority in radiological fusion at 24 months;ODI success;Fusion success;Neurological success;No serious adverse events that are 'related';No additional surgeries classified as failure;Evidence of bridging bone. Fusion is based on evidence of continuous bone bridging from the superior to the inferior vertebral body at the target level(s) in at least 1 of the following locations: right lateral, left lateral, anterior, posterior, or through the PEEK implant.;No evidence of motion as defined by less than 2 mm translational motion and less than 3o in angular motion at each treated level (flexion/extension radiographs).; | — |
Secondary
| Measure | Time frame |
|---|---|
| demonstrating superiority in overall success at 24 months postoperatively for the investigational group as compared to the control group if non-inferiority is achieved;assessing whether statistical difference exists between the investigational groups and the control group for the secondary endpoints. Superiority of these endpoints will be tested in a sequential order.; | — |
Countries
China
Contacts
Public ContactYueming.Song
West China Hospital of Sichuan University
Outcome results
None listed