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Intramedullary Femoral Reaming, Human Study

NCT01042132 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-12-01

No results posted yet for this study

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

Interventions

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.

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)

Sponsors & Collaborators

  • Ullevaal University Hospital

    lead OTHER

Principal Investigators

  • Olav Røise, MD · Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2011-10-31
Completion
2012-05-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01042132 on ClinicalTrials.gov