Osteogenic Cell Viability in Bone Graft
June 20, 2017 updated by: Brett Crist, University of Missouri-Columbia
Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
83
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
-
Columbia, Missouri, United States, 65212
- University of Missouri
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
iliac crest bone graft
Bone graft harvested via iliac crest bone graft procedure
|
iliac crest bone graft procedure
Other Names:
|
|
Reamer Irrigator Aspirator
Bone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure
|
Reamer Irrigator Aspirator (RIA) Procedure
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cell viability
Time Frame: 1 hour post-collection
|
1 hour post-collection
|
|
Osteogenic potential
Time Frame: 1 hour post-collection
|
1 hour post-collection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (ACTUAL)
October 1, 2011
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
January 26, 2009
First Submitted That Met QC Criteria
February 12, 2009
First Posted (ESTIMATE)
February 13, 2009
Study Record Updates
Last Update Posted (ACTUAL)
June 21, 2017
Last Update Submitted That Met QC Criteria
June 20, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 1095798
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.