Intramedullary Femoral Reaming, Human Study
Primary Purpose
Pulmonary Complications, Organ Failure, Systemic Inflammatory Response Syndrome
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
the effect of delayed intramedullary reaming
the reaming of the femoral canal is performed with two different reaming devices
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Complications focused on measuring intramedullary reaming, inflammatory response, human, femoral shaft fracture, Reamer-irrigator-aspirator
Eligibility Criteria
Inclusion Criteria:
- femoral shaft fracture suitable for intramedullary nailing
- < 24 hours postinjury
Exclusion Criteria:
- previous fracture of the femur
- pathological fracture
- femur deformities
- pregnancy
- previous intramedullary nailing or external fixation
Sites / Locations
- Orthopedic Center, Ullevål University Hopspital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1) IMN and EF/IMN
2) TR and RIA
Arm Description
Two parts of the study are randomized; 1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing
Two parts of the study are randomized; 2)traditional reaming (TR)is compared to a new reaming device, RIA, which is a reamer connected to suction and flushing for prevention of increased intramedullary pressure
Outcomes
Primary Outcome Measures
cardiopulmonary alterations
coagulation, fibrinolytic and cytokine response
Secondary Outcome Measures
fracture healing
Full Information
NCT ID
NCT01042132
First Posted
January 4, 2010
Last Updated
November 30, 2016
Sponsor
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01042132
Brief Title
Intramedullary Femoral Reaming, Human Study
Official Title
Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ullevaal University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).
Detailed Description
To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Complications, Organ Failure, Systemic Inflammatory Response Syndrome
Keywords
intramedullary reaming, inflammatory response, human, femoral shaft fracture, Reamer-irrigator-aspirator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1) IMN and EF/IMN
Arm Type
Active Comparator
Arm Description
Two parts of the study are randomized;
1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing
Arm Title
2) TR and RIA
Arm Type
Active Comparator
Arm Description
Two parts of the study are randomized; 2)traditional reaming (TR)is compared to a new reaming device, RIA, which is a reamer connected to suction and flushing for prevention of increased intramedullary pressure
Intervention Type
Procedure
Intervention Name(s)
the effect of delayed intramedullary reaming
Intervention Description
in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed.
Intervention Type
Procedure
Intervention Name(s)
the reaming of the femoral canal is performed with two different reaming devices
Intervention Description
the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA)
Primary Outcome Measure Information:
Title
cardiopulmonary alterations
Time Frame
the first three postoperative days
Title
coagulation, fibrinolytic and cytokine response
Time Frame
pre-, per- and first 3 days postoperatively
Secondary Outcome Measure Information:
Title
fracture healing
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
femoral shaft fracture suitable for intramedullary nailing
< 24 hours postinjury
Exclusion Criteria:
previous fracture of the femur
pathological fracture
femur deformities
pregnancy
previous intramedullary nailing or external fixation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Røise, MD
Organizational Affiliation
Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway
Official's Role
Study Director
Facility Information:
Facility Name
Orthopedic Center, Ullevål University Hopspital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Intramedullary Femoral Reaming, Human Study
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