Clinical trial NCT02297581: Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program
Official title: A Prospective Multicenter Cohort Study to Evaluate the Benefit of the Geriatric Fracture Center (GFC) Concept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Keywords: Geriatrics [MeSH]
Osteoporotic fractures [MeSH]
Hip fractures [MeSH]
Cost benefit analysis [MeSH]
Quality of life [MeSH]
Mortality [MeSH]
Complications
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 282
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic (Usual Care clinic) Geriatric center

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Events related to treatment / residential status / immobilization
timeFrame: From surgery up to 1 year follow-up
Secondary outcomes:
measure: Any other AEs not mentioned under primary outcome measure(s) as well as its relationship to the treatment / residential status / immobilization
timeFrame: From surgery up to 1 year follow-up
measure: Activities of daily living
timeFrame: Baseline, 12 weeks and 1 year postoperative
measure: Number of re-admissions to an acute hospital
timeFrame: From surgery up to 1 year follow-up
measure: Timed up and go test (TUG)
timeFrame: 12 weeks and 1 year follow-up
measure: Parker Mobility Score
timeFrame: Baseline, 12 weeks and 1 year follow-up
measure: Mortality
timeFrame: From surgery up to 1 year follow-up
measure: Quality of Life
timeFrame: 12 weeks and 1 year postoperative
measure: Pain
timeFrame: From surgery up to1 year follow-up
measure: Direct and indirect costs
timeFrame: Baseline up to 1 year follow-up
measure: Time from admission to start of pain medication
timeFrame: Baseline (admission to surgery), about 1-2 days
measure: Time from admission to start of fluid management
timeFrame: Baseline (admission to surgery), about 1-2 days
measure: Time from admission to surgery
timeFrame: Baseline (admission to surgery), about 1-2 days
measure: Time from surgery to discharge 1 and 2
timeFrame: Baseline (admission to discharge), about 1-2 weeks
measure: Residential status
timeFrame: Baseline up to 1 year follow-up
measure: Falls
timeFrame: From surgery up to 1 year follow-up
measure: Medication
timeFrame: Baseline up to 1 year follow-up
measure: Number of patients receiving adequate secondary fracture prevention
timeFrame: Baseline up to 1 year follow-up
measure: Number of patients for which the nutrition status was evaluated / adapted
timeFrame: Baseline (admission to discharge), about 1-2 days
measure: Occurrence of a contralateral hip fracture
timeFrame: Retrospective assessment of pre-injury status up to 1 year follow-up
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: New York
country: United States
facility: Elmhurst Medical Center
state: New York
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Linz
country: Austria
facility: AKH Linz
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Singapore
country: Singapore
facility: General Hospital Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Palma de Mallorca
country: Spain
facility: Hospital Son LLatzer
state: Balearic Island
city: Marbella
country: Spain
facility: Hospital Universitario Costa del Sol
city: Bangkok
country: Thailand
facility: Bhumibol Adulyadej Hospital
city: Bangkok
country: Thailand
facility: Hospital Medical Center Bangkok
Study officials:
affiliation: Medical University of Innsbruck
name: Michael Blauth, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blauth M, Joeris A, Rometsch E, Espinoza-Rebmann K, Wattanapanom P, Jarayabhand R, Poeze M, Wong MK, Kwek EBK, Hegeman JH, Perez-Uribarri C, Guerado E, Revak TJ, Zohner S, Joseph D, Gosch M. Geriatric fracture centre vs usual care after proximal femur fracture in older patients: what are the benefits? Results of a large international prospective multicentre study. BMJ Open. 2021 May 10;11(5):e039960. doi: 10.1136/bmjopen-2020-039960.
citation: Hurtado-Chong A, Joeris A, Hess D, Blauth M. Improving site selection in clinical studies: a standardised, objective, multistep method and first experience results. BMJ Open. 2017 Jul 12;7(7):e014796. doi: 10.1136/bmjopen-2016-014796.
citation: Joeris A, Hurtado-Chong A, Hess D, Kalampoki V, Blauth M. Evaluation of the geriatric co-management for patients with fragility fractures of the proximal femur (Geriatric Fracture Centre (GFC) concept): protocol for a prospective multicentre cohort study. BMJ Open. 2017 Jul 12;7(7):e014795. doi: 10.1136/bmjopen-2016-014795.