Osteogenic Cell Viability in Bone Graft

• Sponsor: University of Missouri-Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00843973
• Collaborator: AO North America (Other)
• Enrollment: 83
• Location: 1
• Duration (Months): 66
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fractures, Closed	Procedure: iliac crest bone graft; Procedure: Reamer Irrigator Aspirator

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 Design

• Study Type: Observational
• Actual Enrollment: 83 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
iliac crest bone graft Bone graft harvested via iliac crest bone graft procedure	Procedure: iliac crest bone graft; iliac crest bone graft procedure; Other Names: ICBG
Reamer Irrigator Aspirator Bone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure	Procedure: Reamer Irrigator Aspirator; Reamer Irrigator Aspirator (RIA) Procedure; Other Names: RIA

Outcome Measures

Primary Outcome Measures

1. Cell viability [1 hour post-collection]

2. Osteogenic potential [1 hour post-collection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri	Columbia	Missouri	United States	65212

Sponsors and Collaborators

• University of Missouri-Columbia
• AO North America

Investigators

• Principal Investigator: Brett D Crist, MD, University of Missouri-Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brett Crist, Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT00843973
• Other Study ID Numbers: IRB 1095798
• First Posted: Feb 13, 2009
• Last Update Posted: Jun 21, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Brett Crist, Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia: Iliac Crest Bone Graft; Reamer Irrigator Aspirator
• Additional relevant MeSH terms: Fractures, Closed

Study Results

No Results Posted as of Jun 21, 2017