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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03532945
• Date of registration: 02/05/2018
• Prospective Registration: No
• Primary sponsor: BioAlpha Inc.
• Public title: A Follow-up Study to Evaluate the Efficacy and Safety of Novomax in Posterior Lumbar Interbody Fusion
• Scientific title: 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
• Date of first enrolment: October 28, 2010
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03532945
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Contacts

• Name: Ki Hyoung Koo, MD. PhD.
• Affiliation: DongGuk University

• Name: Jae Hyup Lee, MD. PhD.
• Affiliation: SMG-SNU Boramae Medical Center

• Name: Ho-Joong Kim, MD. PhD.
• Affiliation: Seoul National University Bundang Hospital

• Name: Bong-Soon Chang, MD. PhD.
• Affiliation: Seoul National University Hospital

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Degenerative Lumbar Spinal Stenosis

Intervention(s)

Device: Titanium cage

Device: Bioactive Glass-Ceramic Spacer

Primary Outcome(s)

Bone fusion with radiographs (X-ray) [Time Frame: for 36 months after surgery]

Secondary Outcome(s)

The SF(Short Form)-36 questionnaire assessment [Time Frame: for 36 months after surgery]

VAS for target site [Time Frame: for 36 months after surgery]

1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: for 36 months after surgery]

The Oswestry Disability Index(ODI) assessment [Time Frame: for 36 months after surgery]

Bone fusion with 3-dimensional computed tomography(CT) [Time Frame: for 36 months after surgery]

Secondary ID(s)

B1504

Source(s) of Monetary Support

Please refer to primary and secondary sponsors