lumbar stenosis, spondylolisthesis, spondylolysis, scoliosis, instability, disc disease
Conditions
Interventions
The investigational medicinal product is an osteogenic agent in which the modified human recombinant bone morphogenetic protein AMP2 is bound to the absorbable bone regeneration material ReBOSSIS-J.
T
Sponsors
Tokuyama Ryusuke
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese patients aged 18 years or older at the time of informed consent, with fully matured skeletal development. 2. Patients for whom single-level lumbar interbody fusion is indicated due to lumbar spinal canal stenosis, degenerative spondylolisthesis, lumbar spondylolysis/spondylolisthesis, degenerative lumbar scoliosis, lumbar instability, or lumbar disc disease. 3. Patients whose general medical condition is stable and who are eligible for surgical intervention. 4. Male patients or female patients who are postmenopausal (including menopause due to oophorectomy). 5. Patients who have received a sufficient explanation of the study and have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients requiring surgery at more than one intervertebral level. 2. Patients with a history of lumbar fusion surgery (including decompression with fusion) at the affected level; however, patients with a history of decompression alone are not excluded. 3. Patients whose bone mineral density (BMD) by DEXA is less than 70% of the young adult mean (YAM), or patients with osteoporosis for whom lumbar fusion surgery is judged to be contraindicated at the investigator's discretion. 4. Patients with a BMI of 40 or higher. 5. Patients with an existing malignant tumor, or those who have received radiotherapy or chemotherapy for a malignant tumor within the past five years from the time of informed consent. Patients who underwent tumor resection alone, or those who received only hormonal therapy as postoperative adjuvant therapy, are not excluded. 6. Patients with an active systemic infection or an infection at the planned surgical site. 7. Patients with a history of smoking (including electronic cigarettes and nicotine-containing products) within 30 days prior to surgery. 8. Patients with systemic diseases such as lupus, Reiter's disease, rheumatic disorders, or autoimmune diseases requiring immunosuppressive therapy including biologics, or other systemic inflammatory conditions. 9. Patients with diabetes mellitus whose glycemic control is inadequate. 10. Patients with endocrine or metabolic disorders known to affect bone metabolism. 11. Patients who have received any of the following medications that may affect bone healing within four weeks prior to surgery: 11-1. Bone-forming agents (PTH analogues) 11-2. Anti-sclerostin monoclonal antibodies 11-3. Systemic corticosteroids or corticosteroid-containing products 11-4. Immunosuppressive agents 12. Patients with a history of hypersensitivity or allergy to the investigational product or medical devices used in the study. 13. Patients who are unable to practice appropriate contraception during the study period. 14. Patients with prior exposure to recombinant proteins or peptides used for bone formation. 15. Patients who have participated in another clinical study within one year prior to investigational product administration. 16. Patients deemed unsuitable for participation in this study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone fusion assessed by CT at 52 weeks postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bone fusion assessed by CT at 26 weeks postoperatively. 2. Bone fusion assessed by radiography at 26, 39, and 52 weeks postoperatively. 3. Change from baseline in NRS scores for low back pain and lower extremity pain due to degenerative lumbar disease at 12, 26, 39, and 52 weeks postoperatively. 4. Change from baseline in ODI at 12, 26, 39, and 52 weeks postoperatively. 5. Change from baseline in JOABPEQ at 12, 26, 39, and 52 weeks postoperatively. 6. Change from baseline in EQ-5D-5L at 12, 26, 39, and 52 weeks postoperatively. 7. Presence or absence of secondary surgical interventions due to nonunion or pseudoarthrosis up to week 52. Safety evaluation: Adverse events Pharmacokinetic assessment of AMP2 CT imaging assessments at 2, 6, 12, 26, and 52 weeks postoperatively Radiographic assessments at 2, 6, 12, 26, 39, and 52 weeks postoperatively | — |
Contacts
Public ContactRyusuke Tokuyama
ORTHOREBIRTH CO. LTD.
Outcome results
None listed