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Anterior Gen Plus Study

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ClinicalTrials.gov Identifier: NCT04629807
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
SeaSpine, Inc.

Study Description
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Brief Summary:
A clinical study evaluating patients treated with the Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM) in anterior lumbar interbody fusion.

Condition or disease Intervention/treatment Phase
Spine Fusion Procedure: Anterior Lumbar Interbody Fusion (ALIF) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anterior Gen Plus Study
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Demineralized Bone Matrix (DBM) Procedure: Anterior Lumbar Interbody Fusion (ALIF)
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)
Active Comparator: Cellular Bone Matrix (CBM) Procedure: Anterior Lumbar Interbody Fusion (ALIF)
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of fusion for the DBM versus CBM cohorts [ Time Frame: 12 months ]
    Proportion of levels exhibiting fusion for the DBM cohort versus the CBM cohort


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years of age
  • 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:

  • Signs of acute infection
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629807


Contacts
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Contact: Tish Mikoczi 760-216-5652 tish.mikoczi@seaspine.com
Contact: Frank Vizesi, PhD 760.216.5138 frank.vizesi@seaspine.com

Locations
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United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Kelly Tundo, RN    313-916-1102    Kciach1@hfhs.org   
Principal Investigator: Muwaffak Abdulhak, MD         
Sub-Investigator: Mohamed Macki, MD         
Sub-Investigator: Travis Hamilton, MD         
Sponsors and Collaborators
SeaSpine, Inc.
Investigators
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Principal Investigator: Muwaffak Abdulhak, MD Henry Ford Health System
More Information
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Responsible Party: SeaSpine, Inc.
ClinicalTrials.gov Identifier: NCT04629807    
Other Study ID Numbers: SS-OS-1901
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No