Clinical trial NCT00843973: Osteogenic Cell Viability in Bone Graft
Official title: Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures, Closed
Keywords: Iliac Crest Bone Graft
Reamer Irrigator Aspirator
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: AO North America
First posted: 2009-02-13
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Cell viability
timeFrame: 1 hour post-collection
measure: Osteogenic potential
timeFrame: 1 hour post-collection
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Brett D Crist, MD
role: PRINCIPAL_INVESTIGATOR
References: