Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AO North America
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00843973
First received: January 26, 2009
Last updated: March 2, 2011
Last verified: March 2011

January 26, 2009
March 2, 2011
June 2008
December 2010   (final data collection date for primary outcome measure)
  • Cell viability [ Time Frame: 1 hour post-collection ] [ Designated as safety issue: No ]
  • Osteogenic potential [ Time Frame: 1 hour post-collection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00843973 on ClinicalTrials.gov Archive Site
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Not Provided
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Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft
Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Project involves comparison of small samples taken from patients undergoing iliac crest or medullary reaming for comparison and review

Fractures, Closed
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
  • 1 - ICBG
    Bone graft harvested via iliac crest bone graft procedure
    Intervention: Other: cell viability and osteogenic potential analysis
  • 2 - RIA
    Bone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure
    Intervention: Other: cell viability and osteogenic potential analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects age 18 years or older
  • Subjects undergoing a bone grafting procedure, either using an iliac crest or RIA system harvesting technique, or
  • Subjects undergoing reamed femoral intramedullary nailing using the RIA reaming technique

Exclusion Criteria:

  • Subjects under age 18
  • Subjects with a history of: leukemia; cancer with bone metastases; renal failure, receiving dialysis; or on immunosuppressive medications
Both
18 Years and older
No
Contact: Brett D. Crist, MD 573-882-6562
United States
 
NCT00843973
IRB 1095798
No
Brett D. Crist, MD, University of Missouri
University of Missouri-Columbia
AO North America
Principal Investigator: Brett D Crist, MD University of Missouri-Columbia
University of Missouri-Columbia
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP