Anterior Gen Plus Study

SeaSpine

Status: Active, not recruiting

Conditions: Spine Fusion

Treatments: Procedure: Anterior Lumbar Interbody Fusion (ALIF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04629807

SS-OS-1901

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Demineralized Bone Matrix (DBM)

Active Comparator group

Description:

All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Study Implant (one-level) implanted with Demineralized Bone Matrix (DBM).

Treatment:

Procedure: Anterior Lumbar Interbody Fusion (ALIF)

Cellular Bone Matrix (CBM)

Active Comparator group

Description:

All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Control Implant (one-level) implanted with Cellular Bone Matrix (CBM).

Treatment:

Procedure: Anterior Lumbar Interbody Fusion (ALIF)