Osteogenic Cell Viability in Bone Graft

Completed

• Conditions: Fractures, Closed
• Interventions: Procedure: iliac crest bone graft; Procedure: Reamer Irrigator Aspirator

• Registration Number: NCT00843973
• Lead Sponsor: University of Missouri-Columbia

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.

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Primary Completion: 2011-10
• Study Completion: 2013-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
iliac crest bone graft	iliac crest bone graft	Bone graft harvested via iliac crest bone graft procedure
Reamer Irrigator Aspirator	Reamer Irrigator Aspirator	Bone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure

Primary Outcome Measures

Name	Time	Method
Cell viability	1 hour post-collection
Osteogenic potential	1 hour post-collection

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States