Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture (FEMO)
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 Design:||Time Perspective: Prospective|
|Official Title:||Can a Multimodal Approach Improve the Outcome of Patients With a Proximal Femoral Fracture?|
- 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 ]
|Study Start Date:||March 2012|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
commonly used therapy
Device: PulsioFlex® Monitoring
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673776
|Contact: Bettina Jungwirth, MD||+49 89 4140 ext firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Bettina Jungwirth, MD|
|Sub-Investigator: Aida Anetsberger, MD|
|Sub-Investigator: Sebastian Schmid, MD|
|Sub-Investigator: Manfred Blobner, MD|
|Principal Investigator:||Bettina Jungwirth, MD||Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München|