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

Not Applicable

Completed

• Conditions: Proximal Femoral Fracture
• Interventions: Device: PulsioFlex® Monitoring

• Registration Number: NCT01673776
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-28
• Primary Completion: 2016-10
• Study Completion: 2016-10-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M group	PulsioFlex® Monitoring	multimodal intervention

Primary Outcome Measures

Name	Time	Method
postoperative complications	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

Secondary Outcome Measures

Name	Time	Method
duration of the stay at the hospital	1 year
intensive care duration	1 year
mortality	1 year

Trial Locations

Locations (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munic, Bavaria, Germany