Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture (FEMO)
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|ClinicalTrials.gov Identifier: NCT01673776|
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : January 19, 2017
|Condition or disease||Intervention/treatment|
|Proximal Femoral Fracture||Device: PulsioFlex® Monitoring|
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 :||Observational|
|Actual Enrollment :||132 participants|
|Official Title:||Can a Multimodal Approach Improve the Outcome of Patients With a Proximal Femoral Fracture?|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 15, 2016|
commonly used therapy
Device: PulsioFlex® Monitoring
Device: PulsioFlex® Monitoring
- 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
- mortality [ Time Frame: 1 year ]
- duration of the stay at the hospital [ Time Frame: 1 year ]
- intensive care duration [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673776
|Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München|
|Munic, Bavaria, Germany, 81675|
|Principal Investigator:||Bettina Jungwirth, MD||Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München|