Spine Fusion
Conditions
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).
Interventions
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)
Sponsors
SeaSpine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events (SAEs) | 24 Months | SAEs at 24 months |
Countries
United States
Outcome results
None listed