A Follow-up Study to Evaluate the Efficacy and Safety of Novomax in Posterior Lumbar Interbody Fusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Long-term Follow-up Study to Evaluate the Efficacy and Safety for the Patients With Bioactive Glass-ceramic Intervertebral Spacer (Novomax) in Posterior Lumbar Interbody Fusion: Comparison With a Titanium Cage

Conditions
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Degenerative Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: Bioactive Glass-Ceramic Spacer
* Device: Titanium cage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: [In Interventional Study] Subjects who required between L1 and S1 among those who required an extensive laminectomy or facetectomy to correct severe disc extrusion or severe spinal stenosis or those who required PLIF due to grade I or II spondylolisthesis [In Long-term Follow-up Study] Subjects who are treated with bioactive glass ceramic intervertebral spacer or titanium cage in one-level PLIF surgery Exclusion Criteria: [In Interventional Study] Subjects with average T-scores of L1-L4 at <-3.0 in DEXA bone density tests Subjects who are pregnant or breast-feeding Subjects with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study) Subjects with abnormal blood potassium and phosphorus levels Subjects who are considered not suitable for the study by significant disease(liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease) Subjects who are not able to comply with the study requirements Subjects who are considered not suitable for the study by the investigator [In Long-term Follow-up Study] Subjects who are not able to comply with the study requirements Subjects who are considered not suitable for the study by the investigator

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioactive Glass-Ceramic Spacer<br>The one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with Novomax, which is the bioactive glass ceramic intervertebral spacer. | Device: Bioactive Glass-Ceramic Spacer<br> <br> * Other names: Novomax;|
| Active Comparator: Titanium cage<br>The one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with titanium cage. | Device: Titanium cage<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |