Anterior Gen Plus Study
Not Applicable
Active, not recruiting
- Conditions
- Spine Fusion
- Interventions
- Procedure: Anterior Lumbar Interbody Fusion (ALIF)
- Registration Number
- NCT04629807
- Lead Sponsor
- SeaSpine, Inc.
- 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.
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 8
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Demineralized Bone Matrix (DBM) Anterior Lumbar Interbody Fusion (ALIF) All 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) Anterior Lumbar Interbody Fusion (ALIF) All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Control Implant (one-level) implanted with Cellular Bone Matrix (CBM).
- Primary Outcome Measures
Name Time Method Assessment of fusion for the DBM versus CBM cohorts 12 months Proportion of levels exhibiting fusion for the DBM cohort versus the CBM cohort
- Secondary Outcome Measures
Name Time Method Serious Adverse Events (SAEs) 24 Months SAEs at 24 months
Trial Locations
- Locations (1)
Henry Ford Health System
🇺🇸Detroit, Michigan, United States