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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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03532945
Study type Interventional
Source BioAlpha Inc.
Contact
Status Completed
Phase N/A
Start date October 28, 2010
Completion date April 7, 2016
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