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

NCT03532945 | Completed

• 1 other identifier: B1504
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Degenerative Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Bone fusion with 3-dimensional computed tomography(CT)

  for 36 months after surgery

• The Oswestry Disability Index(ODI) assessment

  for 36 months after surgery

• The SF(Short Form)-36 questionnaire assessment

  for 36 months after surgery

• VAS for target site

  for 36 months after surgery

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

  for 36 months after surgery

Study Arms (2)

Bioactive Glass-Ceramic Spacer

EXPERIMENTAL

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

Device: Bioactive Glass-Ceramic Spacer

Titanium cage

ACTIVE COMPARATOR

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

Device: Titanium cage

Interventions

Bioactive Glass-Ceramic Spacer DEVICE

Also known as: Novomax

Bioactive Glass-Ceramic Spacer

Titanium cage DEVICE

Titanium cage

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[In Interventional Study\]
• 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

You may not qualify if:

• \[In Interventional Study\]
• 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

Sponsors & Collaborators

• BioAlpha Inc.: lead

Study Officials

• Bong-Soon Chang, MD. PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Ki Hyoung Koo, MD. PhD.

  DongGuk University

  PRINCIPAL INVESTIGATOR

• Ho-Joong Kim, MD. PhD.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Jae Hyup Lee, MD. PhD.

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 22, 2018
• Study Start: October 28, 2010
• Primary Completion: September 13, 2013
• Study Completion: April 7, 2016
• Last Updated: May 22, 2018

Record last verified: 2018-05