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Bone Graft
Lumbar Fusion Techniques for Spinal Deformity
N/A
Waitlist Available
Led By Michael Chang, MD
Research Sponsored by SeaSpine, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Indicated for deformity correction surgery
≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial looks at whether a certain treatment for spinal deformity is effective.
Who is the study for?
Adults over 18 needing spinal fusion at four or more levels for deformity correction can join. They must commit to follow-up visits and consent to the study. Excluded are those with uncontrolled diabetes, infections, cancer, bone metabolism disorders, prior fusions, prisoners, involved in workers' comp cases or other drug/device studies within 30 days.Check my eligibility
What is being tested?
The trial is comparing two types of spinal fusion techniques for correcting spinal deformities: one using demineralized bone fibers and another with a protein that promotes bone growth. The goal is to see which method works better.See study design
What are the potential side effects?
Potential side effects may include pain at the fusion site, infection risks from surgery, possible allergic reactions to materials used in the procedures, and complications related to bone healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery to correct a deformity.
Select...
I am 18 years old or older.
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I need a spinal fusion surgery involving four or more spine levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort
Secondary outcome measures
Clinical outcomes
Trial Design
2Treatment groups
Active Control
Group I: Demineralized Bone MatrixActive Control1 Intervention
Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM).
Group II: Bone Morphogenic ProteinActive Control1 Intervention
Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP).
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Who is running the clinical trial?
SeaSpine, Inc.Lead Sponsor
8 Previous Clinical Trials
2,499 Total Patients Enrolled
Michael Chang, MDPrincipal InvestigatorSonoran Spine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bones are not strong enough to support treatment.I am currently taking corticosteroids.I am scheduled for surgery to correct a deformity.I am currently taking steroids, immune suppressants, or osteoporosis medications.I have a body-wide infection.I currently have cancer.I have been diagnosed with osteoporosis.My diabetes is not under control.I have a bone metabolism disorder.I have had spinal fusion surgery.I am 18 years old or older.My bones are still growing.I need a spinal fusion surgery involving four or more spine levels.You are using devices that help bones heal faster.You have a history of drinking too much alcohol or using drugs in a harmful way.I am extremely overweight.
Research Study Groups:
This trial has the following groups:- Group 1: Demineralized Bone Matrix
- Group 2: Bone Morphogenic Protein
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.
What is the total number of participants enrolled in this experiment?
"Affirmative. Data available on clinicaltrials.gov verifies that this medical research, initially posted on March 5th 2020, is actively seeking participants. A total of 28 individuals need to be recruited from a single site."
Answered by AI
Are there any vacancies that participants can fill in this clinical trial?
"According to clinicaltrials.gov, this particular medical trial is currently recruiting participants. The study was published on the 5th of March 2020 and has had its details revised as recently as November 10th 2020."
Answered by AI
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