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Bone Graft
BMAC + Allograft vs BMP-2 for Spinal Fusion
N/A
Waitlist Available
Led By Peter Passias
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be 18 years old or older
Scheduled for elective posterior or anterior and posterior spinal fusion of the thoracolumbar spine with or without anterior interbody support
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, year 2
Awards & highlights
Study Summary
This trial is comparing different types of spinal fusion surgery to see which is most effective.
Who is the study for?
This trial is for adults over 18 needing elective spinal fusion surgery, who have tried non-surgical treatments for at least 6 weeks. Candidates should not be pregnant, have a BMI over 40, or suffer from certain bone diseases or allergies to titanium. Prior lumbar surgeries may disqualify them.Check my eligibility
What is being tested?
The study compares three methods of spinal fusion: using the patient's own bone graft (autograft), combining bone marrow concentrate (BMAC) with allograft (donor tissue), and using recombinant human BMP-2. It aims to determine which method is safest and most effective in improving quality of life.See study design
What are the potential side effects?
Potential side effects could include pain at the graft site, infection, inflammation around the spine, allergic reactions to materials used in surgery like BMP-2 or titanium if applicable, and complications related to non-healing of bones.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for a specific type of back surgery involving the middle and lower parts of my spine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, year 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Blood Levels during Intraoperative Period
Change in Blood Levels during Perioperative Period
Change in Euro-Qol 5-Dimension (EQ-5D) Scores from Baseline
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Bone Marrow Aspirate Concentrate (BMAC) + AllograftExperimental Treatment1 Intervention
A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite.
If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1):
1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft)
2-level fusion: 20 cc of BMAC from 120 cc of BMA
3-level fusion: 20 cc of BMAC from 120 cc of BMA
4-level fusion: 180 cc kit
5-level fusion: 240 cc kit
If not using Harvest Graft Delivery Kit:
Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls).
Group II: Recombinant Human Bone Morphogenetic Protein-2 (BMP)Active Control1 Intervention
12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions.
The BMP kit use per level is as follows:
1 Level Fusion: Extra small kit (1.4 cc)
2 Level Fusion: Small Kit (2.8cc)
3 Level Fusion: (4.2 cc)
4 Level Fusion: Medium Kit (5.6cc)
5 Level Fusion: (7.0 cc)
Group III: AutograftActive Control1 Intervention
As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,678 Total Patients Enrolled
Peter PassiasPrincipal InvestigatorNYU Langone Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a laminectomy at the surgery level.I am 18 years old or older.I had cancer but have been symptom-free for over 5 years after treatment.I have a missing or damaged part in my spine.The joints in my spine where the implant is are either missing or broken.I have a bone condition like Paget's disease or osteomalacia.I have tried non-surgical treatments for 6 weeks without improvement.I am not taking any medications that could affect bone or soft tissue healing.I have a recent fracture or damage in my spine where an implant is or will be placed.I have had a lumbar fusion surgery before.I am scheduled for a specific type of back surgery involving the middle and lower parts of my spine.
Research Study Groups:
This trial has the following groups:- Group 1: Bone Marrow Aspirate Concentrate (BMAC) + Allograft
- Group 2: Recombinant Human Bone Morphogenetic Protein-2 (BMP)
- Group 3: Autograft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still active for this research endeavor?
"As indicated by the clinicaltrials.gov database, this study is not presently looking for patients to enrol in it; although first posted on July 24th 2018 and edited most recently on September 6th 2022, 33 other studies are actively recruiting right now."
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