Osteogenic Cell Viability in Bone Graft

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to find out if the cells in bone graft samples collected using a reamer are similar to the cells in bone graft samples collected using the iliac crest bone graft method.

Condition or disease	Intervention/treatment
Fractures, Closed	Procedure: iliac crest bone graft; Procedure: Reamer Irrigator Aspirator

Detailed Description:

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.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	83 participants
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
Study Start Date :	June 2008
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	December 2013

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
iliac crest bone graft; Bone graft harvested via iliac crest bone graft procedure	Procedure: iliac crest bone graft; iliac crest bone graft procedure; Other Name: ICBG
Reamer Irrigator Aspirator; Bone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure	Procedure: Reamer Irrigator Aspirator; Reamer Irrigator Aspirator (RIA) Procedure; Other Name: RIA

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Cell viability [ Time Frame: 1 hour post-collection ]
2. Osteogenic potential [ Time Frame: 1 hour post-collection ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	February 13, 2009
Last Update Posted:	June 21, 2017
Last Verified:	June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Brett Crist, University of Missouri-Columbia:

Iliac Crest Bone Graft; Reamer Irrigator Aspirator

Additional relevant MeSH terms:

Fractures, Closed; Fractures, Bone; Wounds and Injuries