None listed
Conditions
Interventions
Medical Device : This is a bone-forming protein that is inserted into the cage during TLIF surgery and a maximum dose is 1 mg per segment is expected to be used.
Sponsors
Asan Medical Center
Yonsei University Health System, Gangnam Severance Hospital
Chungbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject need to meet the following conditions. 1)Male or female subjects between 18 and 80 years of age. 2)Subjects who diagnosed Degenerative Disc Disease at one or two level from L2 to S1 ?Spinal stenosis ?Herniated Intervertebral disc ?Spondylolisthesis or spondylosis 3) Those who are willing to participate in the trial, comply with treatment and procedures, and visit the hospital for evaluation of all observations. 4)A person who has voluntarily signed a written consent after hearing the purpose and method of this clinical trial.
Exclusion criteria
Exclusion criteria: 1) Those who have a history of spinal surgery or tumor removal at the application site 2) Those with a history of fusion or intervertebral disc replacement in the lumbar region 3) Examples of serious metabolic diseases affecting bone growth, Paget's disease, osteoporosis, osteopenia, myeloma factors 4) Patients with severe osteoporosis, such as those with osteoporosis with an average T score < 3.0 of the lumbar spine L1 to L4 on the DEXA bone density test 5) Patients with hypersensitivity to Hydroxyapatite, rhBMP 2 6) Persons who cannot prohibit drugs that may affect bone metabolism during the prohibition period 7) People with systemic infection and/or acute infection at the site of application. 8) Those who have a history of drug and alcoholism within 2 years 9) It is possible to register if the child's disease with a history of malignancy has been cured and has not relapsed in the past 5 years. 10) Subjects deemed difficult to perform this clinical trial at the judgment of the responsible researcher 11) People with congenital bone and/or spinal cord abnormalities that may affect spinal safety 12) Those who are pregnant or lactating, who are planning to become pregnant during this trial or who do not agree with medically acceptable contraceptive methods. * Medically acceptable contraceptive methods: condoms, oral contraception for at least 3 months, contraceptives for injection or implantation, intrauterine contraceptives, etc. 13) Those who cannot understand the purpose and method of the clinical trial 14) Participants who participated in another medical device intervention clinical trial within 6 months before participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone fusion rate on CT after surgery (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| CT fusion after surgery;X-ray fusion after surgery;ODI score changes compared to before surgery;SF 36 score changes compared to before surgery;VAS score changes compared to before surgery | — |
Countries
Korea, Republic of
Contacts
Public ContactJAE HWAN CHO
Asan Medical Center
Outcome results
None listed