Osteogenic Cell Viability in Bone Graft

Fractures, Closed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843973
• Other study ID #: IRB 1095798
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: June 20, 2017
• Start date: June 2008
• Est. completion date: December 2013

Study information

• Verified date: June 2017
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Closed

Intervention

Procedure:
• iliac crest bone graft
iliac crest bone graft procedure
• Reamer Irrigator Aspirator
Reamer Irrigator Aspirator (RIA) Procedure

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	AO North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell viability		1 hour post-collection
Primary	Osteogenic potential		1 hour post-collection