Clinical trial NCT03532945: 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
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Lumbar Spinal Stenosis
Lead sponsor: BioAlpha Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-22
Enrollment: 62
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bone fusion with radiographs (X-ray)
timeFrame: for 36 months after surgery
Secondary outcomes:
measure: Bone fusion with 3-dimensional computed tomography(CT)
timeFrame: for 36 months after surgery
measure: The Oswestry Disability Index(ODI) assessment
timeFrame: for 36 months after surgery
measure: The SF(Short Form)-36 questionnaire assessment
timeFrame: for 36 months after surgery
measure: VAS for target site
timeFrame: for 36 months after surgery
measure: 1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: for 36 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Bong-Soon Chang, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: DongGuk University
name: Ki Hyoung Koo, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Ho-Joong Kim, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Jae Hyup Lee, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: