Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 26, 2009 | ||||
| Last Updated Date | March 2, 2011 | ||||
| Start Date ICMJE | June 2008 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00843973 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft | ||||
| Official Title ICMJE | Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft | ||||
| Brief Summary | Although iliac crest bone grafting is the gold standard for autogenous bone grafting procedures, limited quantity in some individuals and donor site morbidity have lead surgeons to look for alternative harvest sites or sources such as allograft or osteobiologics. Of these alternative harvest sites is the femoral shaft. Intramedullary contents from reaming are composed of bone marrow, and blood and bone spicules. In this respect, the reamed contents are similar to the bone routinely harvested from the iliac crest. Studies have shown that despite the reaming process using standard reamers, cells maintain their viability and are able to produce new bone. However, the addition of aspiration and irrigation used in the RIA system could potentially compromise the harvested cell viability and limit their osteogenic potential. In addition, Wenisch et al. have concluded that the harvested cells using standard intramedullary reamers not only proceed toward osteogenic differentiation, but also can be directed toward neurogenic differentiation. This suggests that reaming debris is a viable source of stem cells as well. RIA allows for these cells to be harvested. It is our hypothesis that the intramedullary contents harvested using the RIA system is similar to ICBG in cell viability and osteogenic potential. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Project involves comparison of small samples taken from patients undergoing iliac crest or medullary reaming for comparison and review |
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| Condition ICMJE | Fractures, Closed | ||||
| Intervention ICMJE | Other: cell viability and osteogenic potential analysis
Samples from both the ICBG and the RIA groups will be analyzed with flow cytometry, cell culture, transmission electron microscopy, and functional assay for viability and osteogenic differentiation |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00843973 | ||||
| Other Study ID Numbers ICMJE | IRB 1095798 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Brett D. Crist, MD, University of Missouri | ||||
| Study Sponsor ICMJE | University of Missouri-Columbia | ||||
| Collaborators ICMJE | AO North America | ||||
| Investigators ICMJE |
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| Information Provided By | University of Missouri-Columbia | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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