NCT00843973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

3.3 years

First QC Date

January 26, 2009

Last Update Submit

June 20, 2017

Conditions

Fractures, Closed

Keywords

Iliac Crest Bone GraftReamer Irrigator Aspirator

Outcome Measures

Primary Outcomes (2)

  • Cell viability

    1 hour post-collection

  • Osteogenic potential

    1 hour post-collection

Study Arms (2)

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

iliac crest bone graftPROCEDURE

iliac crest bone graft procedure

Also known as: ICBG
iliac crest bone graft
Reamer Irrigator AspiratorPROCEDURE

Reamer Irrigator Aspirator (RIA) Procedure

Also known as: RIA
Reamer Irrigator Aspirator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Project involves comparison of small samples taken from patients undergoing iliac crest or medullary reaming for comparison and review

You may qualify if:

  • 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

You may not qualify if:

  • Subjects under age 18
  • Subjects with a history of: leukemia; cancer with bone metastases; renal failure, receiving dialysis; or on immunosuppressive medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Fractures, Closed

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Brett D Crist, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery

Study Record Dates

First Submitted

January 26, 2009

First Posted

February 13, 2009

Study Start

June 1, 2008

Primary Completion

October 1, 2011

Study Completion

December 1, 2013

Last Updated

June 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)