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Completed

NCT Number: NCT03302520

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

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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Key information

Conditions

Degenerative Lumbar Spinal Stenosis

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovoMax, BioAlpha Inc, Seong-nam, Korea

Device

CaO-SiO2-P2O5-B2O3 glass ceramics spacer

PEEK cage

Device

PEEK cage

Primary outcomes

  1. Fusion rates

    Time frame: up to 5 year after operation

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

Secondary outcomes

  1. Visual Analog Pain Scale (VAS)

    Time frame: 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.

  2. Oswestry Disability Index (ODI)

    Time frame: 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.

  3. EQ-5D

    Time frame: 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.

  4. PainDETECT

    Time frame: 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.

  5. Fusion rates

    Time frame: every year, up to 5 year after operation

    This is assessed by postoperative simple radiography at 1 year after surgery

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 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)

Other outcomes

  1. Operation duration

    Time frame: Immediate after operation

    Intraoperative time

  2. Intraoperative blood loss

    Time frame: Immediate after operation

    Intraoperative blood loss

  3. Postoperative drainage

    Time frame: Within 3 days after operation

    Total drainage after surgery

  4. Amount of transfusion

    Time frame: Within 7 days after operation

    Total transfusion during and after surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Acronym: Novomax

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 5, 2017
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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