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

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Lumbar Spinal Stenosis
• Intervention / Treatment: Device: Bioactive Glass-Ceramic Spacer; Device: Titanium cage

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Bioactive Glass-Ceramic Spacer; Other Names: Novomax
Active Comparator: Titanium cage; The one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with titanium cage.	Device: Titanium cage

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BioAlpha Inc.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2010
• Primary Completion (Actual): September 13, 2013
• Study Completion (Actual): April 7, 2016

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: B1504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No