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

Technical University of Munich

Status: Completed

Conditions: Proximal Femoral Fracture

Treatments: Device: PulsioFlex® Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01673776

FEMO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

K group

No Intervention group

Description:

commonly used therapy

M group

Experimental group

Description:

multimodal intervention

Treatment:

Device: PulsioFlex® Monitoring