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

NCT ID: NCT03532945

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-28
• Study Completion Date: 2016-04-07

Brief Summary

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

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.

Conditions

Degenerative Lumbar Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bioactive Glass-Ceramic Spacer

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

Group Type: EXPERIMENTAL

Bioactive Glass-Ceramic Spacer

Intervention Type: DEVICE

Titanium cage

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

Group Type: ACTIVE_COMPARATOR

Titanium cage

Intervention Type: DEVICE

Interventions

Bioactive Glass-Ceramic Spacer

Intervention Type: DEVICE

Titanium cage

Intervention Type: DEVICE

Other Intervention Names

Novomax

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioAlpha Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bong-Soon Chang, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Ki Hyoung Koo, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

DongGuk University

Ho-Joong Kim, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Jae Hyup Lee, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Other Identifiers

B1504

Identifier Type: -

Identifier Source: org_study_id