Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
28 participants
INTERVENTIONAL
2020-03-05
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Demineralized Bone Matrix
Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM).
Posterolateral Lumbar Fusion with Demineralized Bone Fibers
Posterolateral Lumbar Fusion with Demimeralized Bone Fibers
Bone Morphogenic Protein
Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP).
Posterolateral Lumbar Fusion with Bone Morphogenic Protein
Posterolateral Lumbar Fusion with Bone Morphogenic Protein
Interventions
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Posterolateral Lumbar Fusion with Demineralized Bone Fibers
Posterolateral Lumbar Fusion with Demimeralized Bone Fibers
Posterolateral Lumbar Fusion with Bone Morphogenic Protein
Posterolateral Lumbar Fusion with Bone Morphogenic Protein
Eligibility Criteria
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Inclusion Criteria
* Indicated for deformity correction surgery
* Require spinal fusion at four or more levels
* Are willing to return for follow-up visits
* Willing to sign the Informed Consent Forms
Exclusion Criteria
* Morbid obesity
* history of alcohol or drug abuse
* Corticosteroid use
* Fever or leukocytosis
* Systemic infection
* Active malignancy
* Elevation of white blood cell count
* Osteoporosis
* Disease of bone metabolism
* Unsuitable or insufficient bone support
* Skeletal immaturity
* Prior fusion
* Use of steroids, immune suppressants, osteoporosis medications
* Use of internal bone stimulators
* Institutionalized or a prisoner
* Undergoing (Undergone) a worker's compensation case
* Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration)
* Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during this clinical study
* Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study
18 Years
ALL
No
Sponsors
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SeaSpine, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Chang, MD
Role: PRINCIPAL_INVESTIGATOR
Sonoran Spine
Locations
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Sonoran Spine
Tempe, Arizona, United States
Countries
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Other Identifiers
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SS-OS-1802
Identifier Type: -
Identifier Source: org_study_id
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