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Poor enrollment
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| Name | Class |
|---|---|
| NuTech Medical, Inc | INDUSTRY |
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The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NuCel | Experimental | Stemcell allograft |
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| Demineralized Bone Matrix (DBM) | Active Comparator | Demineralized Bone Matrix (DBM) bone graft substitute |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuCel | Biological |
| ||
| Demineralized Bone Matrix |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | 12 months |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | Baseline |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | 1 month |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | 2 months |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | 3 months |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion | CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion. | 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Shehadi, MD | OhioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States | ||
| Grant Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | NuCel | Stemcell allograft NuCel |
| FG001 | Demineralized Bone Matrix (DBM) | Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2015 |
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| Columbus |
| Ohio |
| 43215 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NuCel | Stemcell allograft NuCel |
| BG001 | Demineralized Bone Matrix (DBM) | Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | Mean | Full Range | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | One of three NuCel patients withdrew before 12 months; therefore, analysis comprises two NuCel patients and three DBM patients. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion | CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion. | The study was terminated due to low enrollment; therefore, CT scans at 6 and 12 months were not conducted. | Posted | 6 and 12 months |
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| Primary | Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
| ||||||||||||||||||||||||||||||
| Primary | Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| Primary | Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
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| Primary | Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Primary | Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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Adverse events were recorded through 12 months post-operatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NuCel | Stemcell allograft NuCel | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | Demineralized Bone Matrix (DBM) | Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix | 0 | 3 | 1 | 3 | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged hospitalization | Gastrointestinal disorders | Non-systematic Assessment | Intermittent diarrhea, bloating, and stomach pain beginning post-operative day 5. Symptoms improved with bowel regimen and liquid diet; solid food resumed post-operative day 5. Patient discharged post-operative day 5. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josepha Shehadi, MD | OhioHealth | 614-220-5648 | joseph@drshehadi.com |
| Apr 12, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| D055009 | Spondylosis |
| D007405 | Intervertebral Disc Displacement |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C497176 | Grafton demineralized bone matrix gel |
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| Between 18 and 65 years |
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| >=65 years |
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