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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
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 4, 2010
Last Updated
November 30, 2016
Sponsor
Ullevaal University Hospital
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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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