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

BioAlpha Inc.62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Degenerative Lumbar Spinal Stenosis

Interventions

Bioactive Glass-Ceramic SpacerDEVICE

Titanium cageDEVICE

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.