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

NCT01673776 | Completed DMC

• 1 other identifier: FEMO
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Femoral Fracture

Keywords

Proximal femoral fracture; multimodal intervention; goal directed therapy (GDT); hemodynamic intervention; outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• mortality

  1 year

• duration of the stay at the hospital

  1 year

• intensive care duration

  1 year

Study Arms (2)

K group

NO INTERVENTION

commonly used therapy

M group

EXPERIMENTAL

multimodal intervention

Device: PulsioFlex® Monitoring

Interventions

PulsioFlex® Monitoring DEVICE

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

M group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• proximal femoral fracture (femoral neck fracture/ pertrochanteric femoral fracture)
• Age ≥ 60 years
• written informed consent

You may not qualify if:

• pathological fracture
• multiple trauma
• fracture during a hospital stay due to a different disease

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

Location

Related Publications (3)

• 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.

  PMID: 19054201 BACKGROUND

• 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.

  PMID: 20966436 BACKGROUND

• 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.

  PMID: 31531828 DERIVED

MeSH Terms

Conditions

Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Bettina Jungwirth, MD

  Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 28, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 15, 2016
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

DE (1)