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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
Must not have
Unsuitable or insufficient bone support
Systemic infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

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.
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.
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 below
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I am scheduled for surgery to correct a deformity.
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I am 18 years old or older.
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I need a spinal fusion surgery involving four or more spine levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My bones are not strong enough to support treatment.
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I have a body-wide infection.
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I currently have cancer.
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I have been diagnosed with osteoporosis.
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My diabetes is not under control.
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I have had spinal fusion surgery.
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My bones are still growing.
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I am extremely overweight.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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).

Find a Location

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

Posterolateral Lumbar Fusion with Bone Morphogenic Protein (Bone Graft) Clinical Trial Eligibility Overview. Trial Name: NCT04629794 — N/A
Spinal Fusion Research Study Groups: Demineralized Bone Matrix, Bone Morphogenic Protein
Spinal Fusion Clinical Trial 2023: Posterolateral Lumbar Fusion with Bone Morphogenic Protein Highlights & Side Effects. Trial Name: NCT04629794 — N/A
Posterolateral Lumbar Fusion with Bone Morphogenic Protein (Bone Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04629794 — N/A
~5 spots leftby Sep 2025
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