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
Not provided
Not provided
Not provided
This is a single-arm post-market study in patients requiring lumbar fusion using allograft interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10 sites. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 6 weeks, 3 months, 6 months, 12 months, and 24 month visit after surgery.
Map3 is an allogeneic bone matrix which also contains demineralized cortical cancellous bone and multipotent adult progenitor cells (MAPC). MAPC-based cells are derived from allograft bone marrow, isolated from other cells and cryopreserved. Both the scaffold and cellular constituents are processed from the same donor but are provided in separate containers. Scaffold and cells combined constitute the implant and must be used together. The map3 implant is available in Strips allograft and Chips allograft configurations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| map3® Cellular Allogeneic Bone Graft | Other | Patients will receive map3® Cellular Allogeneic Bone Graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| map3® Cellular Allogeneic Bone Graft | Other | Patients will receive map3® Cellular Allogeneic Bone Graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Oswestry Disability Index (ODI) | Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion | Fusion at the operated level, based on
| 6 months, 12 months and 24 months |
| Changes in Visual Analog Scale (VAS) pain scores. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaideep Chundri, MD | Carl & Edyth Lindner Center for Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Surgery of Buffalo Niagara, LLC | Niagara Falls | New York | 14304 | United States | ||
| AXIS Neurosurgery and Spine of WNY, PLLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D013168 | Spondylolisthesis |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
| Changes in SF-36 scores. | Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
| Changes in Lumbar Intervertebral Disc (LID) scores. | Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
| Changes in medication use | Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
| Time to return to work | Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months |
| Williamsville |
| New York |
| 14221 |
| United States |
| Carl & Edyth Lindner Center for Research The Christ Hospital | Cincinnati | Ohio | 45219 | United States |