A Multi-center, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02504242

Enrollment

128

Registered

2015-07-21

Start date

2015-04-30

Completion date

Unknown

Last updated

2015-09-01

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

Conditions

Transforaminal Lumbar Interbody Fusion

Brief summary

A Randomized, Subject-Assessor Blind, Multi-center, Comparative Clinical Trial to evaluate the efficacy and safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion.

Interventions

DEVICEInject BMP

PROCEDURELocally Harvested Bone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Inclusion criteria

The subject needs the infusion between the first lumbar vertebrato and the first ilium from those who require posterior spinal instrumentation and interbody fusion for the following reasons, * Spinal stenosis * Spinal disc herniation requiring broad laminectomy * Spondylolisthesis or spondylolysis * Recurrent herniated disc

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
Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks)	at 48 weeks after surgery

Outcome results

None listed

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