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

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Lumbar Spinal Stenosis
• Intervention / Treatment: Device: NovoMax, BioAlpha Inc, Seong-nam, Korea; Device: PEEK cage

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyounggido
    • Seongnam-si, Gyounggido, Korea, Republic of
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novomax; Novomax(R) ceramic glass spacer for interbody fusion	Device: NovoMax, BioAlpha Inc, Seong-nam, Korea; CaO-SiO2-P2O5-B2O3 glass ceramics spacer
Active Comparator: PEEK cage; PEEK cage for interbody fusion	Device: PEEK cage; PEEK cage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion rates	This is assessed by postoperative computed tomography at 1 year after surgery	up to 5 year after operation

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation duration	Intraoperative time	Immediate after operation
Intraoperative blood loss	Intraoperative blood loss	Immediate 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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2017
• Primary Completion (Actual): July 11, 2019
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 30, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: Nvmax_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No