Comparison of Fusion Rate and Clinical Results Between Bioactive Glass Ceramics Spacer With PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, Randomized Controlled Non-inferiority Trial

Seoul National University Hospital1 site in 1 country54 target enrollmentOctober 28, 2017

ConditionsDegenerative Lumbar Spinal Stenosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Degenerative Lumbar Spinal Stenosis
Sponsor: Seoul National University Hospital
Enrollment: 54
Locations: 1
Primary Endpoint: Fusion rates
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 28, 2017

End Date

August 30, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jin S. Yeom

Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Fusion rates

Time Frame: up to 5 year after operation

This is assessed by postoperative computed tomography at 1 year after surgery

Secondary Outcomes

EQ-5D(3, 6, and 12, months, and every year, up to 5 year after operation)
Oswestry Disability Index (ODI)(3, 6, and 12, months, and every year, up to 5 year after operation)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(every year, up to 5 year after operation)
Visual Analog Pain Scale (VAS)(3, 6, and 12, months, and every year, up to 5 year after operation)
PainDETECT(3, 6, and 12, months, and every year, up to 5 year after operation)
Fusion rates(every year, up to 5 year after operation)