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Hip FracturesNCT02297581

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

An observational study of Hip Fractures, run by AO Innovation Translation Center at 12 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Hip Fractures
How many people
282 participants
Where
12 sitesin 6 countries
Study dates
May 2015to May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Primary care clinic (Usual Care clinic) Geriatric center

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

Trial locations and contacts

12 sites in 6 countries.

12 sites in 6 countries

United States2 sites

  • Elmhurst Medical Center

    New York, New York, 11373

  • Saint Louis University

    St Louis, Missouri, 63104

Other trials in United States

Austria2 sites

  • Medical University of Innsbruck

    Innsbruck, 6020

  • AKH Linz

    Linz, 4020

Other trials in Austria

Netherlands2 sites

  • Ziekenhuisgroep Twente

    Almelo, 7609 SZ

  • Maastricht University Medical Center

    Maastricht, 6202 AZ

Other trials in Netherlands

Singapore2 sites

  • General Hospital Singapore

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Spain2 sites

  • Hospital Universitario Costa del Sol

    Marbella, 29603

  • Hospital Son LLatzer

    Palma de Mallorca, Balearic Island, 07198

Other trials in Spain

Thailand2 sites

  • Bhumibol Adulyadej Hospital

    Bangkok, 10220

  • Hospital Medical Center Bangkok

    Bangkok, 10310

Other trials in Thailand

About this study

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

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.

Read the 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.

Conditions
Hip Fractures
Keywords
Geriatrics [MeSH], Osteoporotic fractures [MeSH], Hip fractures [MeSH], Cost benefit analysis [MeSH], Quality of life [MeSH], Mortality [MeSH], Complications
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02297581
Study groupRoleWhat they receive
GFC: Geriatric Fracture CenterPatient treatment in a geriatric fracture center A GFC is defined as follows: * General geriatrician or ortho-geriatrician available in trauma/orthopaedic department * Geriatrician sees the patient prior to surgery (except if the patient is admitted over night or during weekends) * Local medical guidelines, consented by orthopedic surgeons and geriatrician * Pre-defined order set for assessing laboratory values * Pre-defined patient pathway to guarantee a fast track in the emergency room * Daily communication among involved specialists * Postoperative phase up to discharge from orthopaedic / trauma department (i.e. Discharge 1): * Daily patient visit by geriatrician * Daily patient visit by orthopedic surgeon in combination with nurse * Daily therapy by physiotherapists, except for weekends * Access to social workers, if required
UCC: Usual Care CenterPatient treatment in an usual care center A UCC is defined as follows: * No geriatrician available in trauma/orthopaedic department * No pre-operative visit by a geriatrician as a standard * No pre-defined medical guidelines for geriatric fracture patients * Postoperative phase up to discharge from orthopaedic / trauma department (i.e. Discharge 1): * No daily patient visits by a geriatrician as a standard

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From surgery up to 1 year follow-up

Secondary outcomes (19)

  1. Any other AEs not mentioned under primary outcome measure(s) as well as its relationship to the treatment / residential status / immobilization

    Measured: From surgery up to 1 year follow-up

  2. Activities of daily living

    Modified Barthel index pre-injury, at 12 weeks and 12 months

    Measured: Baseline, 12 weeks and 1 year postoperative

  3. Number of re-admissions to an acute hospital

    Measured: From surgery up to 1 year follow-up

  4. Timed up and go test (TUG)

    Measured: 12 weeks and 1 year follow-up

  5. Parker Mobility Score

    Parker Mobility Score pre-injury, at 12 weeks and 12 months

    Measured: Baseline, 12 weeks and 1 year follow-up

  6. Mortality

    Measured: From surgery up to 1 year follow-up

  7. Quality of Life

    Quality of life using the EuroQoL questionnaire (EQ-5D)

    Measured: 12 weeks and 1 year postoperative

  8. Pain

    Pain using the numeric rating scale

    Measured: From surgery up to1 year follow-up

  9. Direct and indirect costs

    All direct and indirect costs will be documented for a cost-effectiveness analysis (medication, treatment, physiotherapy, postoperative care etc)

    Measured: Baseline up to 1 year follow-up

  10. Time from admission to start of pain medication

    Measured: Baseline (admission to surgery), about 1-2 days

  11. Time from admission to start of fluid management

    Measured: Baseline (admission to surgery), about 1-2 days

  12. Time from admission to surgery

    Measured: Baseline (admission to surgery), about 1-2 days

  13. 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.

    Measured: Baseline (admission to discharge), about 1-2 weeks

  14. Residential status

    Pre-injury, at discharge 1 and 2, at 12 weeks and 12 months

    Measured: Baseline up to 1 year follow-up

  15. Falls

    Numbers of falls

    Measured: From surgery up to 1 year follow-up

  16. 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

    Measured: Baseline up to 1 year follow-up

  17. Number of patients receiving adequate secondary fracture prevention

    Measured: Baseline up to 1 year follow-up

  18. Number of patients for which the nutrition status was evaluated / adapted

    Measured: Baseline (admission to discharge), about 1-2 days

  19. Occurrence of a contralateral hip fracture

    Measured: Retrospective assessment of pre-injury status up to 1 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2014 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2019
  4. Study completionMay 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02297581
Sponsor's protocol ID
GFC
Status last verified
Jan 2019
First submitted
17 Nov 2014
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • Joeris A, Sprague S, Blauth M, Gosch M, Wattanapanom P, Jarayabhand R, Poeze M, Wong MK, Kwek EBK, Hegeman JH, Perez-Uribarri C, Guerado E, Revak TJ, Zohner S, Joseph D, Phillips MR. Cost-effectiveness analysis of the Geriatric Fracture Center (GFC) concept: a prospective multicentre cohort study. BMJ Open. 2023 Nov 2;13(11):e072744. doi: 10.1136/bmjopen-2023-072744.

    PubMed 37918921

  • 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.

    PubMed 33972329

  • 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.

    PubMed 28706090

  • 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.

    PubMed 28706089

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Fractures, run by AO Innovation Translation Center at 12 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Austria, Netherlands, Singapore, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Events related to treatment / residential status / immobilization (time frame: From surgery up to 1 year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02297581, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

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