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Completed

NCT Number: NCT02297581

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

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.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major Adverse Events related to treatment / residential status / immobilization

    Time frame: From surgery up to 1 year follow-up

    Major AEs related to treatment / residential status / immobilization:

    • Delirium
    • Congestive heart failure
    • Pneumonia
    • Deep venous thrombosis
    • Pulmonary embolism
    • Pressure ulcers
    • Myocardial infarction

Secondary outcomes

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

    Time frame: From surgery up to 1 year follow-up

  2. Activities of daily living

    Time frame: Baseline, 12 weeks and 1 year postoperative

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

  3. Number of re-admissions to an acute hospital

    Time frame: From surgery up to 1 year follow-up

  4. Timed up and go test (TUG)

    Time frame: 12 weeks and 1 year follow-up

  5. Parker Mobility Score

    Time frame: Baseline, 12 weeks and 1 year follow-up

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

  6. Mortality

    Time frame: From surgery up to 1 year follow-up

  7. Quality of Life

    Time frame: 12 weeks and 1 year postoperative

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

  8. Pain

    Time frame: From surgery up to1 year follow-up

    Pain using the numeric rating scale

  9. Direct and indirect costs

    Time frame: Baseline up to 1 year follow-up

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

  10. Time from admission to start of pain medication

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

  11. Time from admission to start of fluid management

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

  12. Time from admission to surgery

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

  13. Time from surgery to discharge 1 and 2

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

    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.

  14. Residential status

    Time frame: Baseline up to 1 year follow-up

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

  15. Falls

    Time frame: From surgery up to 1 year follow-up

    Numbers of falls

  16. Medication

    Time frame: Baseline up to 1 year follow-up

    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

  17. Number of patients receiving adequate secondary fracture prevention

    Time frame: Baseline up to 1 year follow-up

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

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

  19. Occurrence of a contralateral hip fracture

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

Sponsors and collaborators

Lead sponsor

AO Innovation Translation Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Nov 21, 2014
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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