Osteogenic Cell Viability in Bone Graft

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fractures, Closed

Intervention / Treatment
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* Procedure: iliac crest bone graft
* Procedure: Reamer Irrigator Aspirator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| iliac crest bone graft<br>Bone graft harvested via iliac crest bone graft procedure | Procedure: iliac crest bone graft<br>* iliac crest bone graft procedure<br>* Other names: ICBG;|
| Reamer Irrigator Aspirator<br>Bone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure | Procedure: Reamer Irrigator Aspirator<br>* Reamer Irrigator Aspirator (RIA) Procedure<br>* Other names: RIA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell viability |  | 1 hour post-collection | 
| Osteogenic potential |  | 1 hour post-collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iliac Crest Bone Graft, Reamer Irrigator Aspirator