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Intramedullary Femoral Reaming, Human Study

NCT ID: NCT01042132

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2012-05-31

Brief Summary

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

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Pulmonary Complications Organ Failure Systemic Inflammatory Response Syndrome

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1) IMN and EF/IMN

Two parts of the study are randomized;

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

Group Type ACTIVE_COMPARATOR

the effect of delayed intramedullary reaming

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elisabeth Ellingsen Husebye

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olav Røise, MD

Role: STUDY_DIRECTOR

Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway

Locations

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Orthopedic Center, Ullevål University Hopspital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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02066

Identifier Type: -

Identifier Source: org_study_id