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OpenTrials
Completed

NCT Number: NCT00843973

Osteogenic Cell Viability in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iliac Crest Bone Graft

Procedure

iliac crest bone graft procedure

Other names: ICBG

Reamer Irrigator Aspirator

Procedure

Reamer Irrigator Aspirator (RIA) Procedure

Other names: RIA

Primary outcomes

  1. Cell viability

    Time frame: 1 hour post-collection

  2. Osteogenic potential

    Time frame: 1 hour post-collection

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • AO North America

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Feb 13, 2009
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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