None listed
Conditions
Interventions
Medical Device : After performing the necessary examinations and tests according to the protocol, only subjects who meet the inclusion/exclusion criteria are assigned a subject number according to pre
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female subjects aged 19 years or older and 80 years or younger 2) Patients with pain associated with thoracic and lumbar spinal deformity disease at 3 to 5 segments between L5 and SI who plan to perform intertransverse process lateral fusion 3) Those who voluntarily agreed to participate in this clinical trial and provided written consent. *In general, spinal deformity is diagnosed when spinal deformity occurs more than 3 levels at thoracic and lumbar spinal. This clinical trial is performed for patients with thoracic and lumbar spinal deformity disease at 3 to 5 segments between L1 and S1 who plan to perform intertransverse process lateral fusion
Exclusion criteria
Exclusion criteria: 1) Patients who have participated in other clinical trials within one month prior to enrollment in this clinical trial and received drug administration or medical device treatment 2) Those who have had fusion surgery in the same area 3) Osteoporosis on DEXA bone density test (average T-score is -3.5 under in lumbar spine L1~L4) 4) Immunosuppression or autoimmune disease 5) Patients with hypersensitivity to rhBMP-2 6) Those with a history of malignant tumors (allow to enroll if the disease has been completely cured and has not recurred in the past 5 years) 7) Those with fractures, acute infections, hemorrhagic diseases, active systemic infections, osteodystrophy, or infections at the surgical site 8) Patients with serious diseases that the investigator determines may affect surgery (e.g., heart failure, kidney failure, liver failure, uncontrolled blood pressure, diabetes, blood coagulation disorder, etc.) 9) Those who take (or plan to take) contraindicated concomitant drugs 10) Those with alcohol or drug addiction, mental illness 11) Pregnant women, lactating women, and patients who are planning to become pregnant during this clinical trial period or the women of childbearing potential who do not agree to the use of medically accepted contraceptive methods during the trial period * Medically accepted contraceptive methods: condoms, oral contraceptives lasting for at least 3 months, injectable or implantable contraceptives, and intrauterine contraceptives, etc. 12) Others, if judged by the investigator to be inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone fusion rate by computed tomography (CT scan). | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone fusion rate on computed tomography (CT scan);Changes in the proximal junctional angle on X-ray;Changes in pain evaluated by 100 mm VAS (Visual Analog Scale) ;Changes in quality of life evaluated by the Korean version of Oswestry Disability Index (ODI);Changes in quality of life evaluated by SF-36;Changes in quality of life evaluated by SRS-22 | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung-Jae Hyun
Seoul National University Bundang Hospital
Outcome results
None listed