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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novomax | Experimental | Novomax(R) ceramic glass spacer for interbody fusion |
|
| PEEK cage | Active Comparator | PEEK cage for interbody fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovoMax, BioAlpha Inc, Seong-nam, Korea | Device | CaO-SiO2-P2O5-B2O3 glass ceramics spacer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion rates | This is assessed by postoperative computed tomography at 1 year after surgery | up to 5 year after operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3, 6, and 12, months, and every year, up to 5 year after operation |
| Oswestry Disability Index (ODI) |
| Measure | Description | Time Frame |
|---|---|---|
| Operation duration | Intraoperative time | Immediate after operation |
| Intraoperative blood loss | Intraoperative blood loss | Immediate after operation |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyounggido | South Korea |
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| PEEK cage |
| Device |
PEEK cage |
|
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. |
| 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. | 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. | 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 | 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) | every year, up to 5 year after operation |
| Postoperative drainage | Total drainage after surgery | Within 3 days after operation |
| Amount of transfusion | Total transfusion during and after surgery | Within 7 days after operation |