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

Proximal Femoral Fracture Clinical Trial

— FEMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673776
• Other study ID #: FEMO
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: October 15, 2016

Study information

• Verified date: August 2018
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 15, 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Proximal Femoral Fracture

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München	Munic	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. Review. — View Citation

Pedersen SJ, Borgbjerg FM, Schousboe B, Pedersen BD, Jørgensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications	postoperative complications: cardiovascular, cerebrovascular, pulmonal, renal and surgical complications	The participants will be followed for the duration of hospital stay, an expected average of 14 days
Secondary	mortality		1 year
Secondary	duration of the stay at the hospital		1 year
Secondary	intensive care duration		1 year