Osteogenic Cell Viability in Bone Graft

NCT ID: NCT00843973

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

Fractures, Closed

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

iliac crest bone graft

Bone graft harvested via iliac crest bone graft procedure

iliac crest bone graft

Intervention Type: PROCEDURE

iliac crest bone graft procedure

Reamer Irrigator Aspirator

Bone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure

Reamer Irrigator Aspirator

Intervention Type: PROCEDURE

Reamer Irrigator Aspirator (RIA) Procedure

Interventions

iliac crest bone graft

iliac crest bone graft procedure

Intervention Type: PROCEDURE

Reamer Irrigator Aspirator

Reamer Irrigator Aspirator (RIA) Procedure

Intervention Type: PROCEDURE

Other Intervention Names

ICBG; RIA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO North America

OTHER

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Brett Crist

Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brett D Crist, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

Other Identifiers

IRB 1095798

Identifier Type: -

Identifier Source: org_study_id