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

Primary Purpose

Degenerative Lumbar Spinal Stenosis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Bioactive Glass-Ceramic Spacer

Titanium cage

About this trial

This is an interventional treatment trial for Degenerative Lumbar Spinal Stenosis

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bioactive Glass-Ceramic Spacer

Titanium cage

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Evaluation of AE

Full Information

NCT ID

NCT03532945

First Posted

May 2, 2018

Last Updated

May 10, 2018

Sponsor

BioAlpha Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03532945

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

October 28, 2010 (Actual)

Primary Completion Date

September 13, 2013 (Actual)

Study Completion Date

April 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioAlpha Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Lumbar Spinal Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bioactive Glass-Ceramic Spacer

Arm Type

Experimental

Arm Description

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

Arm Title

Titanium cage

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Bioactive Glass-Ceramic Spacer

Other Intervention Name(s)

Novomax

Intervention Type

Device

Intervention Name(s)

Titanium cage

Primary Outcome Measure Information:

Title

Bone fusion with radiographs (X-ray)

Description

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

Time Frame

for 36 months after surgery

Secondary Outcome Measure Information:

Title

Bone fusion with 3-dimensional computed tomography(CT)

Description

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.

Time Frame

for 36 months after surgery

Title

The Oswestry Disability Index(ODI) assessment

Description

Evaluation of the Oswestry disability index questionnaire survey for 36 months(or more than 36 months) after PLIF surgery.

Time Frame

for 36 months after surgery

Title

The SF(Short Form)-36 questionnaire assessment

Description

Evaluation of the SF(Short Form)-36 questionnaire survey for 36 months(or more than 36 months) after PLIF surgery.

Time Frame

for 36 months after surgery

Title

VAS for target site

Description

Evaluation of target site pain using the visual analogue scale (VAS) for 36 months(or more than 36 months) after PLIF surgery.

Time Frame

for 36 months after surgery

Title

1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Description

Evaluation of AE

Time Frame

for 36 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bong-Soon Chang, MD. PhD.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ki Hyoung Koo, MD. PhD.

Organizational Affiliation

DongGuk University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ho-Joong Kim, MD. PhD.

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jae Hyup Lee, MD. PhD.

Organizational Affiliation

SMG-SNU Boramae Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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