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
8 participants
INTERVENTIONAL
2020-09-15
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Demineralized Bone Matrix (DBM)
All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Study Implant (one-level) implanted with Demineralized Bone Matrix (DBM).
Anterior Lumbar Interbody Fusion (ALIF)
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)
Cellular Bone Matrix (CBM)
All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Control Implant (one-level) implanted with Cellular Bone Matrix (CBM).
Anterior Lumbar Interbody Fusion (ALIF)
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)
Interventions
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Anterior Lumbar Interbody Fusion (ALIF)
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)
Eligibility Criteria
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Inclusion Criteria
* Requires anterior lumbar interbody (ALIF) fusion
* Are physically and mentally able and willing to return for the scheduled follow up visits, follow post-operative instructions
* Willing and able to sign study specific Informed Consent Form
Exclusion Criteria
* Active malignancy and/or current chemotherapy
* Prior fusion at operative or adjacent level
* Institutionalized or a prisoner
* Documented history of alcohol or drug abuse
* Undergoing a worker's compensation case
* Pregnancy
* Participation in another research study involving another implant or drug that may affect the outcomes of 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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Muwaffak Abdulhak, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Locations
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Henry Ford Health System
Detroit, Michigan, United States
Countries
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Other Identifiers
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SS-OS-1901
Identifier Type: -
Identifier Source: org_study_id
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