NCT02425514

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

May 21, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

April 21, 2015

Last Update Submit

January 3, 2019

Conditions

Intervertebral Disk DegenerationIntervertebral Disk Displacement

Keywords

Anterior cervical discectomy and fusionNovoMaxBioactive Glass-ceramic Intervertebral Spacer

Outcome Measures

Primary Outcomes (1)

  • Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months)

    Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT and X-ray at 6 months after operation (ACDF).

    at 6 months after surgery (ACDF)

Secondary Outcomes (1)

  • VAS of Neck Pain(Post operative 6 Months)

    at 6 months after surgery (ACDF)

Study Arms (2)

Cervios ChronOs

EXPERIMENTAL

The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.

Device: Cervios ChronOs

NovoMax™

EXPERIMENTAL

The ACDF surgery will be carried out with NovoMax™, which is the bioactive glass ceramic intervertebral spacer

Device: NovoMax™

Interventions

Cervios ChronOsDEVICE

The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.

Cervios ChronOs
NovoMax™DEVICE

The ACDF surgery will be carried out with NovoMax™ after randomization procedure.

NovoMax™

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient who is expected to receive anterior cervical discectomy and fusion operation.
  • Volunteer for this study with written consent.

You may not qualify if:

  • Patient with cervical spine fracture, infection and malignant tumor
  • Below -3.5 T-score by DEXA bone densitometry
  • Patient who is not suitable for this study judged by principal investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc DegenerationIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jin Sup Yeom, MD. Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Treatment group: Bioactive Glass-Ceramic Spacer (NovoMax™) Active comparator: a PEEK cage Filled with β-Tricalcium Phosphate
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

May 21, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

KR(1)