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

Primary Purpose

Degenerative Lumbar Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NovoMax, BioAlpha Inc, Seong-nam, Korea
PEEK cage
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Lumbar Spinal Stenosis

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novomax

PEEK cage

Arm Description

Novomax(R) ceramic glass spacer for interbody fusion

PEEK cage for interbody fusion

Outcomes

Primary Outcome Measures

Fusion rates
This is assessed by postoperative computed tomography at 1 year after surgery

Secondary Outcome Measures

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.
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.
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.
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.
Fusion rates
This is assessed by postoperative simple radiography at 1 year after surgery
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)

Full Information

First Posted
September 21, 2017
Last Updated
March 21, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03302520
Brief Title
Comparison of Bioactive Glass Ceramics Spacer and PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, RCT
Acronym
Novomax
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 28, 2017 (Actual)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Novomax
Arm Type
Experimental
Arm Description
Novomax(R) ceramic glass spacer for interbody fusion
Arm Title
PEEK cage
Arm Type
Active Comparator
Arm Description
PEEK cage for interbody fusion
Intervention Type
Device
Intervention Name(s)
NovoMax, BioAlpha Inc, Seong-nam, Korea
Intervention Description
CaO-SiO2-P2O5-B2O3 glass ceramics spacer
Intervention Type
Device
Intervention Name(s)
PEEK cage
Intervention Description
PEEK cage
Primary Outcome Measure Information:
Title
Fusion rates
Description
This is assessed by postoperative computed tomography at 1 year after surgery
Time Frame
up to 5 year after operation
Secondary Outcome Measure Information:
Title
Visual Analog Pain Scale (VAS)
Description
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
Title
Oswestry Disability Index (ODI)
Description
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
Title
EQ-5D
Description
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
Title
PainDETECT
Description
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
Title
Fusion rates
Description
This is assessed by postoperative simple radiography at 1 year after surgery
Time Frame
every year, up to 5 year after operation
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
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
Other Pre-specified Outcome Measures:
Title
Operation duration
Description
Intraoperative time
Time Frame
Immediate after operation
Title
Intraoperative blood loss
Description
Intraoperative blood loss
Time Frame
Immediate after operation
Title
Postoperative drainage
Description
Total drainage after surgery
Time Frame
Within 3 days after operation
Title
Amount of transfusion
Description
Total transfusion during and after surgery
Time Frame
Within 7 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyounggido
Country
Korea, Republic of

12. IPD Sharing Statement

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

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