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

Seoul National University

Status

Completed

Conditions

Degenerative Lumbar Spinal Stenosis

Treatments

Device: NovoMax, BioAlpha Inc, Seong-nam, Korea

Device: PEEK cage

Study type

Interventional

Funder types

Other

Identifiers

NCT03302520

Nvmax_001

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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