Anterior Gen Plus Study
The Anterior Gen Plus Study
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2020
CompletedFirst Submitted
Initial submission to the registry
November 5, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedApril 4, 2023
March 1, 2023
2.3 years
November 5, 2020
March 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of fusion for the DBM versus CBM cohorts
Proportion of levels exhibiting fusion for the DBM cohort versus the CBM cohort
12 months
Secondary Outcomes (1)
Serious Adverse Events (SAEs)
24 Months
Study Arms (2)
Demineralized Bone Matrix (DBM)
ACTIVE COMPARATORAll enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Study Implant (one-level) implanted with Demineralized Bone Matrix (DBM).
Cellular Bone Matrix (CBM)
ACTIVE COMPARATORAll enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Control Implant (one-level) implanted with Cellular Bone Matrix (CBM).
Interventions
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SeaSpine, Inc.lead
Study Sites (1)
Henry Ford Health System
Detroit, Michigan, 48202, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Muwaffak Abdulhak, MD
Henry Ford Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2020
First Posted
November 16, 2020
Study Start
September 15, 2020
Primary Completion
December 16, 2022
Study Completion
April 30, 2023
Last Updated
April 4, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share