Comparison of Bioactive Glass Ceramics Spacer and PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, RCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-28

Study Completion Date

2020-08-30

Brief Summary

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The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics with PEEK cage that is widely used for posterior lumbar interbody fusion (PLIF) surgery in the clinical field.

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Detailed Description

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Conditions

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Degenerative Lumbar Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Novomax

Novomax(R) ceramic glass spacer for interbody fusion

Group Type EXPERIMENTAL

NovoMax, BioAlpha Inc, Seong-nam, Korea

Intervention Type DEVICE

CaO-SiO2-P2O5-B2O3 glass ceramics spacer

PEEK cage

PEEK cage for interbody fusion

Group Type ACTIVE_COMPARATOR

PEEK cage

Intervention Type DEVICE

PEEK cage

Interventions

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NovoMax, BioAlpha Inc, Seong-nam, Korea

CaO-SiO2-P2O5-B2O3 glass ceramics spacer

Intervention Type DEVICE

PEEK cage

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients aged between 30 and 80
* patients who required one-level PLIF 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
* those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form.

Exclusion Criteria

* osteoporosis patients with average T-scores of L1-L4 at \<-3.0 in DEXA bone density tests
* women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
* patients 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)
* patients with abnormal blood potassium and phosphorus levels;
* patients with liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease;
* patients deemed to have less than 1-year life expectancy;
* patients with mental retardation or whose parents or legal guardians were older or had mental disabilities;
* other patients viewed as inappropriate by the staff

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No