Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Demineralized Bone Matrix (DBM) | Active Comparator | 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) | Active Comparator | All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Control Implant (one-level) implanted with Cellular Bone Matrix (CBM). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Lumbar Interbody Fusion (ALIF) | Procedure | Intra-Operative Anterior Lumbar Interbody Fusion (ALIF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of fusion for the DBM versus CBM cohorts | Proportion of levels exhibiting fusion for the DBM cohort versus the CBM cohort | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events (SAEs) | SAEs at 24 months | 24 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Muwaffak Abdulhak, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided