Clinical trial NCT03302520: Comparison of Bioactive Glass Ceramics Spacer and PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, RCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Lumbar Spinal Stenosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Fusion rates
timeFrame: up to 5 year after operation
Secondary outcomes:
measure: Visual Analog Pain Scale (VAS)
timeFrame: 3, 6, and 12, months, and every year, up to 5 year after operation
measure: Oswestry Disability Index (ODI)
timeFrame: 3, 6, and 12, months, and every year, up to 5 year after operation
measure: EQ-5D
timeFrame: 3, 6, and 12, months, and every year, up to 5 year after operation
measure: PainDETECT
timeFrame: 3, 6, and 12, months, and every year, up to 5 year after operation
measure: Fusion rates
timeFrame: every year, up to 5 year after operation
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: every year, up to 5 year after operation
Other outcomes:
measure: Operation duration
timeFrame: Immediate after operation
measure: Intraoperative blood loss
timeFrame: Immediate after operation
measure: Postoperative drainage
timeFrame: Within 3 days after operation
measure: Amount of transfusion
timeFrame: Within 7 days after operation
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggido
Study officials:
References: