Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01439464
Other study ID # BA04-CP01
Secondary ID
Status Recruiting
Phase N/A
First received September 22, 2011
Last updated September 22, 2011
Start date October 2010
Est. completion date June 2013

Study information

Verified date September 2011
Source BioAlpha Inc.
Contact JunHyuk Seo, Ph.D.
Phone 82-31-746-5208
Email seoscy@daewoong.co.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 86
Est. completion date June 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- 30~80 aged patients needed single-level posterior Interbody fusion at L1~S1

- A subject who provided written informed consent to participate in this study

Exclusion Criteria:

- Patitents with BMD T-score < -3.0

- Women who are pregnant or plan to be pregnant within 3 years

- Patient with malignant tumor

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Device:
4 CIS one-touch titanium cage
4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)
Bonglass-SS SSLPB
Bonglass-SS SSLPB(BioAlpha Inc.)

Locations

Country Name City State
Korea, Republic of Dongguk University Medical Center Goyang-si Gyeonggi-do
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul National University Seoul Metropolitan Boramae Medical Center Seoul
Korea, Republic of Seoul National University Bundang Hospital Sungnam-Si Gyeonggi-Do

Sponsors (1)

Lead Sponsor Collaborator
BioAlpha Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiographic assessments of fusion and instability at 12 months after surgery 12 months No
Secondary CT assessments of fusion at 12 months after surgery 12 months No
See also
  Status Clinical Trial Phase
Completed NCT01452022 - Performance of Inductigraft in Spinal Fusion N/A
Withdrawn NCT02371122 - Spinal Cord Stimulation (SCS) Therapy Study N/A
Not yet recruiting NCT01045473 - Prospective Study of Minimally Invasive Spine Surgery N/A