Anterior Gen Plus Study

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.

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).

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