The Clinical Study of Novosis in Posterolateral Fusion

The Clinical Study to Evaluate the Efficacy and Safety of Novosis in Posterolateral Fusion

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01764906

Enrollment

Registered

2013-01-10

Start date

2013-03-31

Completion date

2016-03-31

Last updated

2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterolateral Fusion

Brief summary

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

Interventions

DEVICENovosis

PROCEDUREIliac crest bone graft

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 18\ 80 aged patients needed single-level posterolateral fusion at L1\ S1 * A subject who provided written informed consent to participate in this study

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Fusion grade by CT assessments after surgery	24 weeks

Secondary

Measure	Time frame
Fusion grade by Radiographic assessments after surgery	24 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026