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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Proximal Femoral Fracture

Intervention / Treatment
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* Device: PulsioFlex® Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: K group<br>commonly used therapy | |
| Experimental: M group<br>multimodal intervention | Device: PulsioFlex® Monitoring<br>* goal directed therapy according to PulsioFlex® Monitoring- measurements femoral catheter extended perioperative monitoring nutritional supplementation, (if necessary)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 1 year | 
| duration of the stay at the hospital |  | 1 year | 
| intensive care duration |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proximal femoral fracture, multimodal intervention, goal directed therapy (GDT), hemodynamic intervention, outcome