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

This study has been completed.
Sponsor:
Collaborator:
AO North America
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00843973
First received: January 26, 2009
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Fractures, Closed
Other: cell viability and osteogenic potential analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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 ]

Enrollment: 83
Study Start Date: June 2008
Study Completion Date: December 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 - ICBG
Bone graft harvested via iliac crest bone graft procedure
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
2 - RIA
Bone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843973

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
AO North America
Investigators
Principal Investigator: Brett D Crist, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Brett Crist, Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00843973     History of Changes
Other Study ID Numbers: IRB 1095798
Study First Received: January 26, 2009
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Iliac Crest Bone Graft
Reamer Irrigator Aspirator

Additional relevant MeSH terms:
Fractures, Closed
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014