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

Not Applicable

Completed

• Conditions: Degenerative Lumbar Spinal Stenosis
• Interventions: Device: Bioactive Glass-Ceramic Spacer; Device: Titanium cage

• Registration Number: NCT03532945
• Lead Sponsor: BioAlpha Inc.

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.

Study Timeline

• Study Start: 2010-10-28
• Primary Completion: 2013-09-13
• Study Completion: 2016-04-07
• Status Verified: 2018-05
• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-10
• Last Update Submitted: 2018-05-10
• Study First Posted: 2018-05-22
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bioactive Glass-Ceramic Spacer	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.
Titanium cage	Titanium cage	The one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with titanium cage.

Primary Outcome Measures

Name	Time	Method
Bone fusion with radiographs (X-ray)	for 36 months after surgery	Evaluation of bone fusion between bone substitutes and vertebral endplates with X-ray for 36 months(or more than 36 months) after PLIF surgery.

Secondary Outcome Measures

Name	Time	Method
The Oswestry Disability Index(ODI) assessment	for 36 months after surgery	Evaluation of the Oswestry disability index questionnaire survey for 36 months(or more than 36 months) after PLIF surgery.
The SF(Short Form)-36 questionnaire assessment	for 36 months after surgery	Evaluation of the SF(Short Form)-36 questionnaire survey for 36 months(or more than 36 months) after PLIF surgery.
Bone fusion with 3-dimensional computed tomography(CT)	for 36 months after surgery	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.
VAS for target site	for 36 months after surgery	Evaluation of target site pain using the visual analogue scale (VAS) for 36 months(or more than 36 months) after PLIF surgery.
1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability	for 36 months after surgery	Evaluation of AE