Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program

Hip Fractures Clinical Trial

Official title:

A Prospective Multicenter Cohort Study to Evaluate the Benefit of the Geriatric Fracture Center (GFC) Concept

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297581
• Other study ID #: GFC
• Status: Completed
• Start date: May 2015
• Est. completion date: May 2020

Study information

• Verified date: January 2019
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will assess patients with at least one major AE related to treatment / hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to the usual care group.

Description:

Patients aged ≥ 70 years or older with an osteoporotic hip fracture treated with an osteosynthesis or endoprosthesis will be included in this study.

The primary objective of the study is to assess the difference in the numbers of pre-defined major adverse events (AE) which are related to the treatment, hospitalization and/or immobilization between patients who were treated in a geriatric fracture center or in a usual care center.

As a secondary objective, health economic implications and cost-effectiveness comparison analyses will be performed.

In order to be able to analyze data based on the geographic regions as well as globally, in each participating country, both a Geriatric Fracture Center (GFC) and a Usual Care Center (UCC) will be included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: May 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Preoperative Inclusion Criteria:

• Age = 70 years

• Geriatric patients with hip fractures Treated either with oOsteosynthesis or oEndoprosthesis

• Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form

• Signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved written informed consent

Preoperative Exclusion Criteria:

• Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

• Prisoner

• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
Austria	AKH Linz	Linz
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Maastricht University Medical Center	Maastricht
Singapore	General Hospital Singapore	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Spain	Hospital Universitario Costa del Sol	Marbella
Spain	Hospital Son LLatzer	Palma de Mallorca	Balearic Island
Thailand	Bhumibol Adulyadej Hospital	Bangkok
Thailand	Hospital Medical Center Bangkok	Bangkok
United States	Elmhurst Medical Center	New York	New York
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

United States,  Austria,  Netherlands,  Singapore,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Events related to treatment / residential status / immobilization	Major AEs related to treatment / residential status / immobilization: Delirium; Congestive heart failure; Pneumonia; Deep venous thrombosis; Pulmonary embolism; Pressure ulcers; Myocardial infarction	From surgery up to 1 year follow-up
Secondary	Any other AEs not mentioned under primary outcome measure(s) as well as its relationship to the treatment / residential status / immobilization		From surgery up to 1 year follow-up
Secondary	Activities of daily living	Modified Barthel index pre-injury, at 12 weeks and 12 months	Baseline, 12 weeks and 1 year postoperative
Secondary	Number of re-admissions to an acute hospital		From surgery up to 1 year follow-up
Secondary	Timed up and go test (TUG)		12 weeks and 1 year follow-up
Secondary	Parker Mobility Score	Parker Mobility Score pre-injury, at 12 weeks and 12 months	Baseline, 12 weeks and 1 year follow-up
Secondary	Mortality		From surgery up to 1 year follow-up
Secondary	Quality of Life	Quality of life using the EuroQoL questionnaire (EQ-5D)	12 weeks and 1 year postoperative
Secondary	Pain	Pain using the numeric rating scale	From surgery up to1 year follow-up
Secondary	Direct and indirect costs	All direct and indirect costs will be documented for a cost-effectiveness analysis (medication, treatment, physiotherapy, postoperative care etc)	Baseline up to 1 year follow-up
Secondary	Time from admission to start of pain medication		Baseline (admission to surgery), about 1-2 days
Secondary	Time from admission to start of fluid management		Baseline (admission to surgery), about 1-2 days
Secondary	Time from admission to surgery		Baseline (admission to surgery), about 1-2 days
Secondary	Time from surgery to discharge 1 and 2	Discharge 1 is defined as discharge from orthopaedic / trauma department Discharge 2 is defined as the timepoint when the patient is discharged to their definite residential status, i.e. residential status where no further change in residential status is planned . Discharge 1 and 2 may occur on the same date.	Baseline (admission to discharge), about 1-2 weeks
Secondary	Residential status	Pre-injury, at discharge 1 and 2, at 12 weeks and 12 months	Baseline up to 1 year follow-up
Secondary	Falls	Numbers of falls	From surgery up to 1 year follow-up
Secondary	Medication	Number of different types of medication at admission, discharge 1, 12 weeks, 12 months and information whether analgesics, osteoporosis and other medications are administered at all study visit time points	Baseline up to 1 year follow-up
Secondary	Number of patients receiving adequate secondary fracture prevention		Baseline up to 1 year follow-up
Secondary	Number of patients for which the nutrition status was evaluated / adapted		Baseline (admission to discharge), about 1-2 days
Secondary	Occurrence of a contralateral hip fracture		Retrospective assessment of pre-injury status up to 1 year follow-up