Transforaminal Lumbar Interbody FusionPhase 3NCT02504242
A Multi-center, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion
A Phase 3 study testing Inject BMP and Locally Harvested Bone in people with Transforaminal Lumbar Interbody Fusion, run by BioAlpha Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Transforaminal Lumbar Interbody Fusion
- What is being tested?
- Inject BMP and Locally Harvested Bone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with BMD T-score < -3.0
- Women who are pregnant or plan to be pregnant within study period
About this study
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.
- Conditions
- Transforaminal Lumbar Interbody Fusion
- Being tested
- Inject BMP, Locally Harvested Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inject BMPDevice
Locally Harvested BoneProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Inject BMP | Experimental | ExcelOS Inject / rhBMP-2 Receives: Device: Inject BMP |
| Locally Harvested Bone | Active comparator | Locally Harvested Bone Receives: Procedure: Locally Harvested Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks)
Measured: at 48 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transforaminal Lumbar Interbody FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioAlpha Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504242
- Sponsor's protocol ID
- ExcelOs14-02
- Status last verified
- Jul 2015
- First submitted
- 20 Jul 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT02504242
- Acronym / sponsor ID
- ExcelOs14-02
- Conditions
- Transforaminal Lumbar Interbody Fusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- BioAlpha Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (estimated)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inject BMP | Experimental | Device: Inject BMPExcelOS Inject / rhBMP-2 |
| Locally Harvested Bone | Active comparator | Procedure: Locally Harvested BoneLocally Harvested Bone |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with BMD T-score < -3.0
- Women who are pregnant or plan to be pregnant within study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inject BMP | Device | Inject BMP |
| Locally Harvested Bone | Procedure or surgery | Locally Harvested Bone |
Primary outcome
Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks)
Time frame: at 48 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inject BMP and Locally Harvested Bone in people with Transforaminal Lumbar Interbody Fusion, run by BioAlpha Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks) (time frame: at 48 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.