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NCT04629807 Clinical Trial

Anterior Gen Plus Study

Spine Fusion Clinical Trial

Official title:
The Anterior Gen Plus Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04629807
Other study ID # SS-OS-1901
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date April 30, 2023

Study information
Verified date March 2023
Source SeaSpine, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 8
Est. completion date April 30, 2023
Est. primary completion date December 16, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Anterior Lumbar Interbody Fusion (ALIF)
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)

Locations
Country Name City State
United States Henry Ford Health System Detroit Michigan

Sponsors (1)
Lead Sponsor Collaborator
SeaSpine, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Serious Adverse Events (SAEs) SAEs at 24 months 24 Months
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