Completed

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

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What is being tested

PulsioFlex® Monitoring

Device
Who is being recruted

Femoral Fractures+5

+ Femoral Neck Fractures

+ Hip Fractures

Over 60 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2012
See protocol details

Summary

Principal SponsorTechnical University of Munich
Last updated: August 8, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorTechnical University of Munich
Last updated: August 8, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

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

132 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Femoral FracturesFemoral Neck FracturesHip FracturesLeg InjuriesWounds and InjuriesHip InjuriesFractures, BoneProximal Femoral Fractures

Criteria

3 inclusion criteria required to participate
Age >= 60 years

proximal femoral fracture (femoral neck fracture/ pertrochanteric femoral fracture)

written informed consent

3 exclusion criteria prevent from participating
fracture during a hospital stay due to a different disease

multiple trauma

pathological fracture

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
commonly used therapy

Group II

Experimental
multimodal intervention

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Munich, GermanyOpen Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München in Google Maps
CompletedOne Study Center