ClinicalTrials.gov
ClinicalTrials.gov Menu

Osteogenic Cell Viability in Bone Graft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00843973
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
AO North America
Information provided by (Responsible Party):
Brett Crist, 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.

Condition or disease Intervention/treatment
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 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 : June 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Group/Cohort 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 Name: ICBG

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




Primary Outcome Measures :
  1. Cell viability [ Time Frame: 1 hour post-collection ]
  2. Osteogenic potential [ Time Frame: 1 hour post-collection ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Project involves comparison of small samples taken from patients undergoing iliac crest or medullary reaming for comparison and review
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843973


Locations
United States, Missouri
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

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     History of Changes
Other Study ID Numbers: IRB 1095798
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Brett Crist, University of Missouri-Columbia:
Iliac Crest Bone Graft
Reamer Irrigator Aspirator

Additional relevant MeSH terms:
Fractures, Closed
Fractures, Bone
Wounds and Injuries