NCT01439464

Brief Summary

The goal of this study is to compare Bonglass-SS with titanum cage.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 23, 2011

Status Verified

September 1, 2011

Enrollment Period

2.4 years

First QC Date

September 22, 2011

Last Update Submit

September 22, 2011

Conditions

Degenerative Disk Disease

Outcome Measures

Primary Outcomes (1)

  • Radiographic assessments of fusion and instability at 12 months after surgery

    12 months

Secondary Outcomes (1)

  • CT assessments of fusion at 12 months after surgery

    12 months

Study Arms (2)

Control device

ACTIVE COMPARATOR
Device: 4 CIS one-touch titanium cage

Investigational device

EXPERIMENTAL
Device: Bonglass-SS SSLPB

Interventions

4 CIS one-touch titanium cageDEVICE

4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)

Control device
Bonglass-SS SSLPBDEVICE

Bonglass-SS SSLPB(BioAlpha Inc.)

Investigational device

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~80 aged patients needed single-level posterior Interbody fusion at L1\~S1
  • A subject who provided written informed consent to participate in this study

You may not qualify if:

  • Patitents with BMD T-score \< -3.0
  • Women who are pregnant or plan to be pregnant within 3 years
  • Patient with malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dongguk University Medical Center

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Seoul National University Bundang Hospital

Sungnam-Si, Gyeonggi-do, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Seoul National University Seoul Metropolitan Boramae Medical Center

Seoul, South Korea

RECRUITING

Study Officials

  • JaeHyup Lee, M.D.,Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JunHyuk Seo, Ph.D.

CONTACT

82-31-746-5208seoscy@daewoong.co.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 23, 2011

Study Start

October 1, 2010

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

September 23, 2011

Record last verified: 2011-09

Locations

KR(4)