Status:
COMPLETED
Comparison of Bioactive Glass Ceramics Spacer and PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, RCT
Lead Sponsor:
Seoul National University Hospital
Conditions:
Degenerative Lumbar Spinal Stenosis
Eligibility:
All Genders
30-80 years
Phase:
NA
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 clinic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03302520
Start Date
October 28 2017
End Date
August 30 2020
Last Update
March 23 2022
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyounggido, South Korea