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

Degenerative Lumbar Spinal Stenosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532945
• Other study ID #: B1504
• Status: Completed
• Phase: N/A
• Start date: October 28, 2010
• Est. completion date: April 7, 2016

Study information

• Verified date: May 2018
• Source: BioAlpha Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 7, 2016
• Est. primary completion date: September 13, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• Bioactive Glass-Ceramic Spacer

• Titanium cage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioAlpha Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Evaluation of AE	for 36 months after surgery