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nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone and bone marrow aspirate (BMA) on one side and autograft alone on the opposite side of the treated level(s). It is hypothesized that the use of nanOss Bioactive will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.
The post market clinical investigation is designed to assess instrumented posterolateral fusion (PLF) using nanOss Bioactive bone void filler with autograft bone and bone marrow aspirate in patients with symptomatic spinal stenosis secondary to degenerative disc disease with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1.
Preoperatively, the participant will provide his/her medical history and complete self assessment forms. The investigator will perform a clinical evaluation and x-rays will be performed if recent x-rays are not available. Participants will undergo instrumented PLF with an interbody fusion device (with autograft or allograft) using nanOss Bioactive in combination with autograft bone and bone marrow aspirate in one posterolateral gutter and autograft alone in the opposite posterolateral gutter.
Following surgery, operative and discharge information will be collected and a clinical evaluation will be performed prior to discharge. Participants will be evaluated 6 and 12 months postoperatively. One investigational site will participate in long-term followup of 24 months. Each participant will complete x-rays and self assessment documents. A CT scan performed at the 12 month postoperative visit will be evaluated by an independent radiologist to assess fusion results. Complication data will be recorded throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nanOss Bioactive - posterolateral gutter | Experimental | Participants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nanOss Bioactive - posterolateral gutter | Device | Participants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter. |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion | Based on x-ray and CT scan. Defined as bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion. X-rays obtained at 6 months and 12 months. CT obtained at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Oswestry Disability Index score | As compared to baseline levels | Preoperatively, 6 months, 12 months |
| Improvement in VAS pain scores | As compared to baseline levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications, adverse events and neurological status | Incidence of reoperations, revisions, supplemental fixations, neurological failures, unexpected adverse events or complications will be calculated. Percentage of patients in each category will be reported and exact 95% confidence intervals will be calculated using the inverse beta distribution. | 6 months, 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Eastlack, MD | Scripps Green Hospital | Principal Investigator |
| Thomas Highland, MD | Columbia Orthopedic Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital | La Jolla | California | 92037 | United States | ||
| University of California San Francisco |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 9, 2016 | |
| Reset | Feb 3, 2017 |
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|
| Preoperatively, 6 months, 12 months |
| Improvement in Short Form-36 scores (SF-36) | As compared to baseline levels. | Preoperatively, 6 months, 12 months |
| Decrease in medication usage | As compared to baseline levels. | Preoperatively, 6 months, 12 months |
| Work status | As compared to baseline levels. | Preoperatively, 6 months, 12 months |
| Patient satisfaction | As compared to baseline levels. | Preoperatively, 6 months, 12 months |
| San Francisco |
| California |
| 94143 |
| United States |
| Columbia Orthopedic Group | Columbia | Missouri | 65201 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 9, 2016 | Feb 3, 2017 |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
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