An interventional study of NovoMax, BioAlpha Inc, Seong-nam, Korea and PEEK cage in Degenerative Lumbar Spinal Stenosis, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Novomax(R) ceramic glass spacer for interbody fusion
Device: NovoMax, BioAlpha Inc, Seong-nam, Korea
PEEK cage for interbody fusion
Device: PEEK cage
CaO-SiO2-P2O5-B2O3 glass ceramics spacer
PEEK cage
Fusion rates
This is assessed by postoperative computed tomography at 1 year after surgery
Time frame: up to 5 year after operation
Visual Analog Pain Scale (VAS)
VAS is a measurement score that indicates pain severity status. VAS score comprised a 10-cm line with ''none'' (0) on one end of the scale and ''disabling pain'' (10) on the other.
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
Oswestry Disability Index (ODI)
The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale.20 The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms.
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
EQ-5D
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
PainDETECT
The painDETECT Questionnaire (PDQ) is a screening tool designed to detect neuropathic pain in patients with chronic low back pain (LBP) based on self-reported pain characteristics. The degree of the seven types of pain quality, the type of pain pattern, and the presence of radiating pain. From the three components of the PDQ, a total score is calculated; a high score indicates that the pain is likely to have a neuropathic component. Scoring is performed using a scoring manual, and results in a final screening score: a score of 0-12 indicates nociceptive pain, 19-38 indicates neuropathic pain, and 13-18 indicates mixed pain.
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
Fusion rates
This is assessed by postoperative simple radiography at 1 year after surgery
Time frame: every year, up to 5 year after operation
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Device related adverse events (fracture, translation, subsidence, osteolysis), Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)
Time frame: every year, up to 5 year after operation
Operation duration
Intraoperative time
Time frame: Immediate after operation
Intraoperative blood loss
Intraoperative blood loss
Time frame: Immediate after operation
Postoperative drainage
Total drainage after surgery
Time frame: Within 3 days after operation
Amount of transfusion
Total transfusion during and after surgery
Time frame: Within 7 days after operation
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital