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

NCT03302520 | Completed

• 1 other identifier: Nvmax_001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Fusion rates

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

  up to 5 year after operation

Secondary Outcomes (6)

• Visual Analog Pain Scale (VAS)

  3, 6, and 12, months, and every year, up to 5 year after operation

• Oswestry Disability Index (ODI)

  3, 6, and 12, months, and every year, up to 5 year after operation

• EQ-5D

  3, 6, and 12, months, and every year, up to 5 year after operation

• PainDETECT

  3, 6, and 12, months, and every year, up to 5 year after operation

• Fusion rates

  every year, up to 5 year after operation

Other Outcomes (4)

• Operation duration

  Immediate after operation

• Intraoperative blood loss

  Immediate after operation

• Postoperative drainage

  Within 3 days after operation

Study Arms (2)

Novomax

EXPERIMENTAL

Novomax(R) ceramic glass spacer for interbody fusion

Device: NovoMax, BioAlpha Inc, Seong-nam, Korea

PEEK cage

ACTIVE COMPARATOR

PEEK cage for interbody fusion

Device: PEEK cage

Interventions

NovoMax, BioAlpha Inc, Seong-nam, Korea DEVICE

CaO-SiO2-P2O5-B2O3 glass ceramics spacer

Novomax

PEEK cage DEVICE

PEEK cage

PEEK cage

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 5, 2017
• Study Start: October 28, 2017
• Primary Completion: July 11, 2019
• Study Completion: August 30, 2020
• Last Updated: March 23, 2022

Record last verified: 2022-03

Locations

KR (1)