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Completed

NCT Number: NCT03532945

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

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.

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Key information

Conditions

Degenerative Lumbar Spinal Stenosis

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioactive Glass-Ceramic Spacer

Device

Other names: Novomax

Titanium cage

Device

Primary outcomes

  1. Bone fusion with radiographs (X-ray)

    Time frame: for 36 months after surgery

    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 outcomes

  1. Bone fusion with 3-dimensional computed tomography(CT)

    Time frame: for 36 months after surgery

    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.

  2. The Oswestry Disability Index(ODI) assessment

    Time frame: for 36 months after surgery

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

  3. The SF(Short Form)-36 questionnaire assessment

    Time frame: for 36 months after surgery

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

  4. VAS for target site

    Time frame: for 36 months after surgery

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

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

    Time frame: for 36 months after surgery

    Evaluation of AE

Sponsors and collaborators

Lead sponsor

BioAlpha Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2016
First posted
May 22, 2018
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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