The Use of RIA to Harvest Bone Graft for Treatment of Non-unions and Fractures
RIA
The Use of the Reamer-Irrigator-Aspirator (RIA) to Harvest Bone Graft for Treatment of Non-unions and Fractures
1 other identifier
interventional
21
1 country
1
Brief Summary
This study is to determine the composition of bone graft harvested using the RIA system in 16 orthopaedic trauma patients between age 19 and 65 who have sustained a fracture or non-union requiring bone grafting. The patients will be followed to assess clinical outcomes and associated pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
December 28, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedOctober 1, 2013
September 1, 2013
4 months
December 20, 2007
September 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment of Nonunions and Fractures with Bone Graft
Recruitment:: 1 day; Surgery: 1 day; Follow-up: 12 months
Study Arms (1)
1
OTHERRepair of Orthopaedic Trauma Fractures and Non-Unions
Interventions
Patients must already be scheduled for bone grafting of a fracture or nonunion with harvest of autologous graft material from their femur using the RIA system. The reaming procedure will be conducted using the trochanteric entry portal through the tip of the greater trochanter.
Eligibility Criteria
You may qualify if:
- patient must have a fracture or non-union requiring bone grafting
- adult patient between ages 19 and 65
You may not qualify if:
- primary bone tumors or known metastatic disease involving the bone
- patients with osteomyelitis in the femur that will be used to harvest bone graft
- patients unable or unwilling to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Synthes Inc.collaborator
Study Sites (1)
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, 35294, United States
Related Publications (1)
Hammer TO, Wieling R, Green JM, Sudkamp NP, Schneider E, Muller CA. Effect of re-implanted particles from intramedullary reaming on mechanical properties and callus formation. A laboratory study. J Bone Joint Surg Br. 2007 Nov;89(11):1534-8. doi: 10.1302/0301-620X.89B11.18994.
PMID: 17998197BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Volgas, MD
The University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
December 28, 2007
Study Start
January 1, 2007
Primary Completion
May 1, 2007
Study Completion
September 1, 2009
Last Updated
October 1, 2013
Record last verified: 2013-09