Anterior Gen Plus Study

March 30, 2023 updated by: SeaSpine, Inc.

The Anterior Gen Plus Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective, single-center, clinical study evaluating patients undergoing primary, contiguous 2-level ALIF without supplemental fixation treated with Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM).

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Procedure: Anterior Lumbar Interbody Fusion (ALIF)
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)
Active Comparator: 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).
Procedure: Anterior Lumbar Interbody Fusion (ALIF)
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events (SAEs)
Time Frame: 24 Months
SAEs at 24 months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SeaSpine, Inc.

Investigators

  • Principal Investigator: Muwaffak Abdulhak, MD, Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

December 16, 2022

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SS-OS-1901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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