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A New Clinical Pathway for Patients With Fractured Neck of Femur

1. december 2019 opdateret af: Norwegian University of Science and Technology

A New Clinical Pathway for Patients With Fractured Neck of Femur - The Orthopedics Operate, the Geriatricians Manage the Medical Work-up

The intention is to evaluate the effectiveness of a multi-factorial medical treatment of patients with hip fractures in a specially designed unit for elderly hip fracture patients (orthogeriatric unit) as compared to traditional care in an orthopedic unit.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The intention of the present project is to evaluate the effectiveness of multi-factorial medical treatment of patients with hip fractures in a specially designed geriatric unit for elderly hip fracture patients (orthogeriatric unit) as compared to traditional care in an orthopedic unit.

Every year 9000 patients undergo surgery for hip fractures in Norway. The epidemic of hip fractures is among the most common causes of acute hospitalization of older people and is associated with high morbidity, mortality, disability and subsequent hospital and social costs as well as reduction in quality of life.

Traditionally hip fracture surgery is performed and followed by care in orthopedic departments. Additional rehabilitation within the hospital is sometimes provided by a geriatrician and a team of rehabilitation specialists, but there is a lot of variety in these rehabilitation programmes. Studies have shown improved outcomes when older people were cared for by a specialist multidisciplinary team. However, the results are not conclusive and more research is needed also in that field, as stated by a Cochrane review.

It is well known that hip-fracture patients are frequently characterized by high age, co-morbidity and frailty, which may often be the main reason for falls and injuries as hip fractures. In a previous project performed by our group we showed that by treating acutely sick, frail elderly patients in a geriatric evaluation and management unit mortality was significantly reduced and patients' chances of living at home was improved. Later our research group has focused on assessment and treatment of older persons at risk of falling. Now we have started to focusing on the ultimate consequence of falling in frail elderly people: the hip fracture, through an observational study. The present study is partly also a consequence of this.

The present project will primarily examine the effect of establishing a radical and new clinical pathway for patients with hip fracture starting immediately at admittance to hospital by randomizing patients to treatment in an orthogeriatric unit (intervention group) or to treatment in orthopedic wards (control group) in the emergency department. There will be no specific follow-up after discharge from hospital.

Primary endpoints will evaluate possible effects on mobility as measured by Short Physical Performance Battery (SPPB). As secondary endpoints other relevant functional aspects, site of residence, health economic variables and mortality will be studied. This study will give increased scientific understanding of whether treatment in a specialized orthogeriatric unit can improve outcomes as mobility, the extensive numbers of nursing home admissions and high mortality after a hip fracture.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

397

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

70 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • age >70 years
  • living in nearby municipalities
  • able to walk 10 m before fracture
  • medial, pertrochanteric and subtrochanteric hip-fractures

Exclusion Criteria:

  • nursing home residents
  • expected to die within 3 months
  • pathological fractures

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Orthogeriatric unit
Geriatric work-up on hip-fracture patients
Pre- and postoperative treatment of hip-fracture patients in an orthogeriatric unit(geriatric evaluation and management)
Andre navne:
  • Geriatric work-up in hip-fracture patients
Aktiv komparator: Orthopedic care as usual
Traditional care in the orthopedic unit
treatment in ordinary orthopedic unit

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Mobility
Tidsramme: 1, 4 and 12 months after surgery
1, 4 and 12 months after surgery

Sekundære resultatmål

Resultatmål
Tidsramme
Site of residence
Tidsramme: 1, 4 and 12 months after surgery
1, 4 and 12 months after surgery
Other functional aspects than mobility
Tidsramme: 1, 4 and 12 months after surgery
1, 4 and 12 months after surgery
Health economic variables
Tidsramme: 1, 4 and 12 months after surgery
1, 4 and 12 months after surgery
Mortality
Tidsramme: 1, 4 and 12 months after surgery
1, 4 and 12 months after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Olav Sletvold, MD. Ph D, Department of Neuroscience, Norwegian University of Science and Technology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2008

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

18. april 2008

Først indsendt, der opfyldte QC-kriterier

25. april 2008

Først opslået (Skøn)

28. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 4.2008.335 (REC)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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