Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture (FEMO)
Primary Purpose
Proximal Femoral Fracture
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PulsioFlex® Monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Femoral Fracture focused on measuring Proximal femoral fracture, multimodal intervention, goal directed therapy (GDT), hemodynamic intervention, outcome
Eligibility 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
Sites / Locations
- Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
K group
M group
Arm Description
commonly used therapy
multimodal intervention
Outcomes
Primary Outcome Measures
postoperative complications
postoperative complications: cardiovascular, cerebrovascular, pulmonal, renal and surgical complications
Secondary Outcome Measures
mortality
duration of the stay at the hospital
intensive care duration
Full Information
NCT ID
NCT01673776
First Posted
August 20, 2012
Last Updated
August 6, 2018
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01673776
Brief Title
Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture
Acronym
FEMO
Official Title
Can a Multimodal Approach Improve the Outcome of Patients With a Proximal Femoral Fracture?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Femoral Fracture
Keywords
Proximal femoral fracture, multimodal intervention, goal directed therapy (GDT), hemodynamic intervention, outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
K group
Arm Type
No Intervention
Arm Description
commonly used therapy
Arm Title
M group
Arm Type
Experimental
Arm Description
multimodal intervention
Intervention Type
Device
Intervention Name(s)
PulsioFlex® Monitoring
Intervention Description
goal directed therapy according to PulsioFlex® Monitoring- measurements
femoral catheter
extended perioperative monitoring
nutritional supplementation, (if necessary)
Primary Outcome Measure Information:
Title
postoperative complications
Description
postoperative complications: cardiovascular, cerebrovascular, pulmonal, renal and surgical complications
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of 14 days
Secondary Outcome Measure Information:
Title
mortality
Time Frame
1 year
Title
duration of the stay at the hospital
Time Frame
1 year
Title
intensive care duration
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Jungwirth, MD
Organizational Affiliation
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
City
Munic
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
19054201
Citation
Pedersen SJ, Borgbjerg FM, Schousboe B, Pedersen BD, Jorgensen HL, Duus BR, Lauritzen JB; Hip Fracture Group of Bispebjerg Hospital. A comprehensive hip fracture program reduces complication rates and mortality. J Am Geriatr Soc. 2008 Oct;56(10):1831-8. doi: 10.1111/j.1532-5415.2008.01945.x.
Results Reference
background
PubMed Identifier
20966436
Citation
Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.
Results Reference
background
PubMed Identifier
31531828
Citation
Schmid S, Blobner M, Haas B, Lucke M, Neumaier M, Anetsberger A, Jungwirth B. Perioperative multi-system optimization protocol in elderly hip fracture patients: a randomized-controlled trial. Can J Anaesth. 2019 Dec;66(12):1472-1482. doi: 10.1007/s12630-019-01475-9. Epub 2019 Sep 17.
Results Reference
derived
Learn more about this trial
Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture
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