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Completed

NCT Number: NCT01673776

Multimodal Approach to 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Munich, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PulsioFlex® Monitoring

Device
  • goal directed therapy according to PulsioFlex® Monitoring- measurements
  • femoral catheter
  • extended perioperative monitoring
  • nutritional supplementation, (if necessary)

Primary outcomes

  1. 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 outcomes

  1. mortality

    Time frame: 1 year

  2. duration of the stay at the hospital

    Time frame: 1 year

  3. intensive care duration

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: FEMO

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2012
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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