Fractures, ClosedNCT00843973
Osteogenic Cell Viability in Bone Graft
An observational study of Fractures, Closed, run by University of Missouri-Columbia at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Closed
- What is being tested?
- iliac crest bone graft and Reamer Irrigator Aspirator
- Type of treatment
- Surgery or procedure
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Project involves comparison of small samples taken from patients undergoing iliac crest or medullary reaming for comparison and review
Who may be able to join
- 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
Who cannot join
- Subjects under age 18
- Subjects with a history of: leukemia; cancer with bone metastases; renal failure, receiving dialysis; or on immunosuppressive medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft
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.
- Conditions
- Fractures, Closed
- Being tested
- iliac crest bone graft, Reamer Irrigator Aspirator
- Keywords
- Iliac Crest Bone Graft, Reamer Irrigator Aspirator
- Medical subject headings
- Fractures, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iliac crest bone graftProcedure or surgery
Also called ICBG
iliac crest bone graft procedure
Reamer Irrigator AspiratorProcedure or surgery
Also called RIA
Reamer Irrigator Aspirator (RIA) Procedure
| Study group | Role | What they receive |
|---|---|---|
| iliac crest bone graft | Bone graft harvested via iliac crest bone graft procedure Receives: Procedure: iliac crest bone graft | |
| Reamer Irrigator Aspirator | Bone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure Receives: Procedure: Reamer Irrigator Aspirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell viability
Measured: 1 hour post-collection
Osteogenic potential
Measured: 1 hour post-collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionOct 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, ClosedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- AO North America
- Responsible party
- Principal investigator, Brett Crist, University of Missouri-Columbia
- Investigators
- Brett D Crist, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843973
- Sponsor's protocol ID
- IRB 1095798
- Status last verified
- Jun 2017
- First submitted
- 26 Jan 2009
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteogenic Cell Viability in Bone Graft Obtained Using the Reamer Irrigator Aspirator (RIA) System Versus Iliac Crest Bone Graft
- ClinicalTrials.gov ID
- NCT00843973
- Acronym / sponsor ID
- IRB 1095798
- Conditions
- Fractures, Closed
- Keywords
- Iliac Crest Bone Graft, Reamer Irrigator Aspirator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- AO North America
- Study start
- Jun 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iliac crest bone graft | – | Procedure: iliac crest bone graftBone graft harvested via iliac crest bone graft procedure |
| Reamer Irrigator Aspirator | – | Procedure: Reamer Irrigator AspiratorBone graft harvested via the Reamer Irrigator Aspirator (RIA) Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Project involves comparison of small samples taken from patients undergoing iliac crest or medullary reaming for comparison and review
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects under age 18
- Subjects with a history of: leukemia; cancer with bone metastases; renal failure, receiving dialysis; or on immunosuppressive medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iliac crest bone graftAlso: ICBGiliac crest bone graft procedure | Procedure or surgery | iliac crest bone graft |
| Reamer Irrigator AspiratorAlso: RIAReamer Irrigator Aspirator (RIA) Procedure | Procedure or surgery | Reamer Irrigator Aspirator |
Primary outcome
Cell viability
Time frame: 1 hour post-collection
Osteogenic potential
Time frame: 1 hour post-collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett D Crist, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Closed, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell viability (time frame: 1 hour post-collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.