ClinicalTrials.gg
CompletedNCT00843973Updated Jun 21, 2017

Osteogenic Cell Viability in Bone Graft

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
83
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fractures, Closed

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Keywords

  • Iliac Crest Bone Graft
  • Reamer Irrigator Aspirator
03

In context

Fractures, Closed

44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.

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Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Subjects under age 18
  • Subjects with a history of: leukemia; cancer with bone ; renal failure, receiving dialysis; or on medications
Terms in these criteria, in plain language(2)

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
83 participants (actual)

Groups and cohorts

  • iliac crest bone graft

    Bone graft harvested via iliac crest bone graft procedure

    Procedure: iliac crest bone graft

  • Reamer Irrigator Aspirator

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

    Procedure: Reamer Irrigator Aspirator

Interventions

  • Procedureiliac crest bone graft

    iliac crest bone graft procedure

    Also known as: ICBG

  • ProcedureReamer Irrigator Aspirator

    Reamer Irrigator Aspirator (RIA) Procedure

    Also known as: RIA

06

What researchers measure

Primary outcomes

  1. Cell viability

    Time frame: 1 hour post-collection

  2. Osteogenic potential

    Time frame: 1 hour post-collection

07

Study locations

1 site
  • University of Missouri
    Columbia, Missouri 65212, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

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.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2009
First posted
Feb 13, 2009
Start
Jun 2008
Primary completionActual
Oct 2011
CompletionActual
Dec 2013
Last update
Jun 21, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00843973
Collaborators
AO North America
Responsible party
Brett Crist (Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia) — Principal investigator
First posted
Feb 13, 2009
Start date
Jun 2008
Primary completion
Oct 2011
Completion
Dec 2013
Last update
Jun 21, 2017

Study contacts

Brett D Crist, MD
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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