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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01673776
First received: August 20, 2012
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Proximal Femoral Fracture
Device: PulsioFlex® Monitoring

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Can a Multimodal Approach Improve the Outcome of Patients With a Proximal Femoral Fracture?

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • mortality [ Time Frame: 1 year ]
  • duration of the stay at the hospital [ Time Frame: 1 year ]
  • intensive care duration [ Time Frame: 1 year ]

Estimated Enrollment: 132
Study Start Date: March 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
K group
commonly used therapy
Device: PulsioFlex® Monitoring
  • goal directed therapy according to PulsioFlex- measurements
  • femoral catheter
  • extended perioperative monitoring
  • nutritional supplementation, (if necessary)
M group
multimodal intervention
Device: PulsioFlex® Monitoring
  • goal directed therapy according to PulsioFlex- measurements
  • femoral catheter
  • extended perioperative monitoring
  • nutritional supplementation, (if necessary)

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with proximal femoral fractures (femoral neck fractures or pertrochanteric femoral fractures)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673776

Contacts
Contact: Bettina Jungwirth, MD +49 89 4140 ext 4291 b.jungwirth@lrz.tum.de

Locations
Germany
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München Recruiting
Munic, Bavaria, Germany, 81675
Contact: Bettina Jungwirth, MD    +49 89 4140 ext 4291    b.jungwirth@lrz.tum.de   
Principal Investigator: Bettina Jungwirth, MD         
Sub-Investigator: Aida Anetsberger, MD         
Sub-Investigator: Sebastian Schmid, MD         
Sub-Investigator: Manfred Blobner, MD         
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Bettina Jungwirth, MD Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
  More Information

Publications:
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01673776     History of Changes
Other Study ID Numbers: FEMO
Study First Received: August 20, 2012
Last Updated: March 14, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Proximal femoral fracture
multimodal intervention
goal directed therapy (GDT)
hemodynamic intervention
outcome

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 28, 2014