NCT02504242

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.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

September 1, 2015

Status Verified

July 1, 2015

Enrollment Period

2 years

First QC Date

July 20, 2015

Last Update Submit

August 30, 2015

Conditions

Transforaminal Lumbar Interbody Fusion

Outcome Measures

Primary Outcomes (1)

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

    at 48 weeks after surgery

Study Arms (2)

Inject BMP

EXPERIMENTAL

ExcelOS Inject / rhBMP-2

Device: Inject BMP

Locally Harvested Bone

ACTIVE COMPARATOR

Locally Harvested Bone

Procedure: Locally Harvested Bone

Interventions

Inject BMPDEVICE
Inject BMP
Locally Harvested BonePROCEDURE
Locally Harvested Bone

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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 Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 21, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2017

Last Updated

September 1, 2015

Record last verified: 2015-07