Comparison of Bioactive Glass Ceramics Spacer and PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, RCT

Not Applicable

Completed

• Conditions: Degenerative Lumbar Spinal Stenosis
• Interventions: Device: NovoMax, BioAlpha Inc, Seong-nam, Korea; Device: PEEK cage

• Registration Number: NCT03302520
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-30
• Study First Posted: 2017-10-05
• Study Start: 2017-10-28
• Primary Completion: 2019-07-11
• Study Completion: 2020-08-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novomax	NovoMax, BioAlpha Inc, Seong-nam, Korea	Novomax(R) ceramic glass spacer for interbody fusion
PEEK cage	PEEK cage	PEEK cage for interbody fusion

Primary Outcome Measures

Name	Time	Method
Fusion rates	up to 5 year after operation	This is assessed by postoperative computed tomography at 1 year after surgery

Secondary Outcome Measures

Name	Time	Method
EQ-5D	3, 6, and 12, months, and every year, up to 5 year after operation	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.
Oswestry Disability Index (ODI)	3, 6, and 12, months, and every year, up to 5 year after operation	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.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	every year, up to 5 year after operation	Device related adverse events (fracture, translation, subsidence, osteolysis), Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)
Visual Analog Pain Scale (VAS)	3, 6, and 12, months, and every year, up to 5 year after operation	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.
PainDETECT	3, 6, and 12, months, and every year, up to 5 year after operation	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.
Fusion rates	every year, up to 5 year after operation	This is assessed by postoperative simple radiography at 1 year after surgery

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyounggido, Korea, Republic of