An observational study in Fractures, Closed, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-21.
Sponsored by University of Missouri-Columbia · Observational
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.
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.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
Browse Fractures, Closed studies →University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.
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Project involves comparison of small samples taken from patients undergoing iliac crest or medullary reaming for comparison and review
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bone graft harvested via iliac crest bone graft procedure
Procedure: iliac crest bone graft
Bone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure
Procedure: Reamer Irrigator Aspirator
iliac crest bone graft procedure
Also known as: ICBG
Reamer Irrigator Aspirator (RIA) Procedure
Also known as: RIA
Cell viability
Time frame: 1 hour post-collection
Osteogenic potential
Time frame: 1 hour post-collection
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jun 2008, a primary completion of Oct 2011 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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