Intramedullary Femoral Reaming, Human Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2002 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01042132
First received: January 4, 2010
Last updated: August 8, 2011
Last verified: April 2002
  Purpose

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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).


Condition Intervention
Pulmonary Complications
Organ Failure
Systemic Inflammatory Response Syndrome
Procedure: the effect of delayed intramedullary reaming
Procedure: the reaming of the femoral canal is performed with two different reaming devices

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • cardiopulmonary alterations [ Time Frame: the first three postoperative days ] [ Designated as safety issue: No ]
  • coagulation, fibrinolytic and cytokine response [ Time Frame: pre-, per- and first 3 days postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fracture healing [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: May 2003
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1) IMN and EF/IMN

Two parts of the study are randomized;

1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing

Procedure: the effect of delayed intramedullary reaming
in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed.
Active Comparator: 2) TR and RIA
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
Procedure: the reaming of the femoral canal is performed with two different reaming devices
the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042132

Locations
Norway
Orthopedic Center, Ullevål University Hopspital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Director: Olav Røise, MD Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway
  More Information

No publications provided

Responsible Party: Olav Røise, MD, Orthopedic Centre, Ullevaal University Hospital, Orthopedic Centre, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT01042132     History of Changes
Other Study ID Numbers: 02066
Study First Received: January 4, 2010
Last Updated: August 8, 2011
Health Authority: Norway: Ethics Committee

Keywords provided by Oslo University Hospital:
intramedullary reaming
inflammatory response
human
femoral shaft fracture
Reamer-irrigator-aspirator

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on October 16, 2014