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This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody fusion.
During one-level PLIF, bioactive glass-ceramic intervertebral spacer (Novomax) and titanium cage were inserted in the experimental group and control group, respectively. Bone fusion by simple radiography had angular deformity of less than 3 degrees and a potential of less than 3 mm in flexion extension radiographs, and thin-section CT (<2 mm) was used to determine the combination between the vertebral endplate and the autogenous bone or bioactive glass-ceramic intervertebral spacer (Novomax) in the cage without any gaps or the part connected to bony trabecula as fusion, and both groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioactive Glass-Ceramic Spacer | Experimental | The one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with Novomax, which is the bioactive glass ceramic intervertebral spacer. |
|
| Titanium cage | Active Comparator | The one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with titanium cage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioactive Glass-Ceramic Spacer | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bone fusion with radiographs (X-ray) | Evaluation of bone fusion between bone substitutes and vertebral endplates with X-ray for 36 months(or more than 36 months) after PLIF surgery. | for 36 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Bone fusion with 3-dimensional computed tomography(CT) | Evaluation of bone fusion between bone substitutes and vertebral endplates with 3-dimensional CT for 36 months(or more than 36 months) after PLIF surgery. | for 36 months after surgery |
| The Oswestry Disability Index(ODI) assessment |
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Inclusion Criteria:
[In Interventional Study]
[In Long-term Follow-up Study]
Exclusion Criteria:
[In Interventional Study]
[In Long-term Follow-up Study]
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| Name | Affiliation | Role |
|---|---|---|
| Bong-Soon Chang, MD. PhD. | Seoul National University Hospital | Principal Investigator |
| Ki Hyoung Koo, MD. PhD. | DongGuk University | Principal Investigator |
| Ho-Joong Kim, MD. PhD. | Seoul National University Bundang Hospital | Principal Investigator |
| Jae Hyup Lee, MD. PhD. | SMG-SNU Boramae Medical Center | Principal Investigator |
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| Titanium cage |
| Device |
|
Evaluation of the Oswestry disability index questionnaire survey for 36 months(or more than 36 months) after PLIF surgery. |
| for 36 months after surgery |
| The SF(Short Form)-36 questionnaire assessment | Evaluation of the SF(Short Form)-36 questionnaire survey for 36 months(or more than 36 months) after PLIF surgery. | for 36 months after surgery |
| VAS for target site | Evaluation of target site pain using the visual analogue scale (VAS) for 36 months(or more than 36 months) after PLIF surgery. | for 36 months after surgery |
| 1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Evaluation of AE | for 36 months after surgery |