Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture (FEMO)

August 6, 2018 updated by: Technical University of Munich

Can a Multimodal Approach Improve the Outcome of Patients With a Proximal Femoral Fracture?

This study is designed to compare the outcome of patients with proximal femoral fractures with different perioperative regimes: a group with a multimodal intervention and a control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Femoral neck fractures constitute both a social and economic challenge. The one year mortality of affected patients amounts to 33%, wherein cardio-vascular complications are the major contributor. It is an objective of the present study to investigate whether a multi-modal perioperative intervention can improve the outcome of these patients.

We plan to carry out a prospective randomized controlled clinical study. Patients with an age above 60 years and proximal femoral fractures (femoral neck fractures or pertrochanteric femoral fractures) are to be included. These are divided into two groups, K and M. General anaesthesia is applied to both groups. In group K a commonly used therapy will be applied whereas in group M an intesified perioperative care will be carried out. The objectives are to provide sufficient analgesia, normotonia and normothermia. Hence, a femoral catheter is applied for pain therapy already preoperatively. Moreover, the pulmonal situation is improved by means of oxygen as needed. The cardiovascular situation is evaluated and optimized by means of extended hemodynamic monitoring both pre- and postoperatively. If needed, the nutrition of the patients is supplemented with highly caloric drinks.

A primary common endpoint is the appearance of postoperative complications. These include cardiovascular, cerebrovascular, pulmonal, renal and surgical complications. Secondary endpoints are mortality, duration of the stay at the hospital and intensive care duration. It is the objective of the study to reduce the probability for at least one postoperative complication from 50% to 25% (α=0,05 and 1-β=0,80). To this end 132 patients would have to be included in the study.

All participants are to be contacted by phone one year after the surgery and their health situation is to be determined.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munic, Bavaria, Germany, 81675
        • Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • proximal femoral fracture (femoral neck fracture/ pertrochanteric femoral fracture)
  • Age ≥ 60 years
  • written informed consent

Exclusion Criteria:

  • pathological fracture
  • multiple trauma
  • fracture during a hospital stay due to a different disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: K group
commonly used therapy
Experimental: M group
multimodal intervention
Device: PulsioFlex® Monitoring
  • goal directed therapy according to PulsioFlex® Monitoring- measurements
  • femoral catheter
  • extended perioperative monitoring
  • nutritional supplementation, (if necessary)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: The participants will be followed for the duration of hospital stay, an expected average of 14 days
postoperative complications: cardiovascular, cerebrovascular, pulmonal, renal and surgical complications
The participants will be followed for the duration of hospital stay, an expected average of 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 1 year
1 year
duration of the stay at the hospital
Time Frame: 1 year
1 year
intensive care duration
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Bettina Jungwirth, MD, Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 15, 2016

Study Registration Dates

First Submitted

August 20, 2012

First Submitted That Met QC Criteria

August 23, 2012

First Posted (Estimate)

August 28, 2012

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEMO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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