NCT01764906

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Novosis in posterolateral fusion

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 22, 2015

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

January 7, 2013

Last Update Submit

April 21, 2015

Conditions

Posterolateral Fusion

Outcome Measures

Primary Outcomes (1)

  • Fusion grade by CT assessments after surgery

    24 weeks

Secondary Outcomes (1)

  • Fusion grade by Radiographic assessments after surgery

    24 weeks

Study Arms (2)

Novosis

EXPERIMENTAL

Bongros/rhBMP-2

Device: Novosis

Iliac crest bone graft

ACTIVE COMPARATOR

Iliac crest bone graft

Procedure: Iliac crest bone graft

Interventions

NovosisDEVICE
Novosis
Iliac crest bone graftPROCEDURE
Iliac crest bone graft

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with BMD T-score \< -3.0
  • Women who are pregnant or plan to be pregnant within study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 10, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

April 22, 2015

Record last verified: 2013-01

Locations

KR(1)