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

BioAlpha

Status: Completed

Conditions: Degenerative Lumbar Spinal Stenosis

Treatments: Device: Bioactive Glass-Ceramic Spacer; Device: Titanium cage

Study type: Interventional

Funder types: Industry

Identifiers

NCT03532945

B1504

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Bioactive Glass-Ceramic Spacer

Experimental group

Description:

The one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with Novomax, which is the bioactive glass ceramic intervertebral spacer.

Treatment:

Device: Bioactive Glass-Ceramic Spacer

Titanium cage

Active Comparator group

Description:

The one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with titanium cage.

Treatment:

Device: Titanium cage