Intramedullary Femoral Reaming, Human Study

NCT01042132 | Completed

• 1 other identifier: 02066
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

Conditions

Pulmonary Complications; Organ Failure; Systemic Inflammatory Response Syndrome

Keywords

intramedullary reaming; inflammatory response; human; femoral shaft fracture; Reamer-irrigator-aspirator

Outcome Measures

Primary Outcomes (2)

• cardiopulmonary alterations

  the first three postoperative days

• coagulation, fibrinolytic and cytokine response

  pre-, per- and first 3 days postoperatively

Secondary Outcomes (1)

• fracture healing

  1 year

Study Arms (2)

1) IMN and EF/IMN

ACTIVE COMPARATOR

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

2) TR and RIA

ACTIVE COMPARATOR

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

Interventions

the effect of delayed intramedullary reaming PROCEDURE

in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed.

1) IMN and EF/IMN

the reaming of the femoral canal is performed with two different reaming devices PROCEDURE

the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA)

2) TR and RIA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• femoral shaft fracture suitable for intramedullary nailing
• \< 24 hours postinjury

You may not qualify if:

• previous fracture of the femur
• pathological fracture
• femur deformities
• pregnancy
• previous intramedullary nailing or external fixation

Sponsors & Collaborators

• Ullevaal University Hospital: lead

Study Sites (1)

Orthopedic Center, Ullevål University Hopspital

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Olav Røise, MD

  Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: May 1, 2003
• Primary Completion: October 1, 2011
• Study Completion: May 1, 2012
• Last Updated: December 1, 2016

Record last verified: 2002-04

Locations

NO (1)