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A New Clinical Pathway for Patients With Fractured Neck of Femur

Primary Purpose

Hip Fracture, Aged

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
geriatric work-up
Orthopedic care as usual
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring Hip-unit, Geriatric care, Mobility, Site of residence

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Orthogeriatric unit

    Orthopedic care as usual

    Arm Description

    Geriatric work-up on hip-fracture patients

    Traditional care in the orthopedic unit

    Outcomes

    Primary Outcome Measures

    Mobility

    Secondary Outcome Measures

    Site of residence
    Other functional aspects than mobility
    Health economic variables
    Mortality

    Full Information

    First Posted
    April 18, 2008
    Last Updated
    December 1, 2019
    Sponsor
    Norwegian University of Science and Technology
    Collaborators
    The Research Council of Norway, Helse Nord-Trøndelag HF
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00667914
    Brief Title
    A New Clinical Pathway for Patients With Fractured Neck of Femur
    Official Title
    A New Clinical Pathway for Patients With Fractured Neck of Femur - The Orthopedics Operate, the Geriatricians Manage the Medical Work-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (Actual)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology
    Collaborators
    The Research Council of Norway, Helse Nord-Trøndelag HF

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Fracture, Aged
    Keywords
    Hip-unit, Geriatric care, Mobility, Site of residence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    397 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Orthogeriatric unit
    Arm Type
    Experimental
    Arm Description
    Geriatric work-up on hip-fracture patients
    Arm Title
    Orthopedic care as usual
    Arm Type
    Active Comparator
    Arm Description
    Traditional care in the orthopedic unit
    Intervention Type
    Procedure
    Intervention Name(s)
    geriatric work-up
    Other Intervention Name(s)
    Geriatric work-up in hip-fracture patients
    Intervention Description
    Pre- and postoperative treatment of hip-fracture patients in an orthogeriatric unit(geriatric evaluation and management)
    Intervention Type
    Procedure
    Intervention Name(s)
    Orthopedic care as usual
    Intervention Description
    treatment in ordinary orthopedic unit
    Primary Outcome Measure Information:
    Title
    Mobility
    Time Frame
    1, 4 and 12 months after surgery
    Secondary Outcome Measure Information:
    Title
    Site of residence
    Time Frame
    1, 4 and 12 months after surgery
    Title
    Other functional aspects than mobility
    Time Frame
    1, 4 and 12 months after surgery
    Title
    Health economic variables
    Time Frame
    1, 4 and 12 months after surgery
    Title
    Mortality
    Time Frame
    1, 4 and 12 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olav Sletvold, MD. Ph D
    Organizational Affiliation
    Department of Neuroscience, Norwegian University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21510886
    Citation
    Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Prestmo A, Lamb SE, Aamodt A, Johnsen R, Magnussen J, Saltvedt I. Effect of in-hospital comprehensive geriatric assessment (CGA) in older people with hip fracture. The protocol of the Trondheim Hip Fracture trial. BMC Geriatr. 2011 Apr 21;11:18. doi: 10.1186/1471-2318-11-18.
    Results Reference
    background
    PubMed Identifier
    26895846
    Citation
    Prestmo A, Saltvedt I, Helbostad JL, Taraldsen K, Thingstad P, Lydersen S, Sletvold O. Who benefits from orthogeriatric treatment? Results from the Trondheim hip-fracture trial. BMC Geriatr. 2016 Feb 19;16:49. doi: 10.1186/s12877-016-0218-1.
    Results Reference
    background
    PubMed Identifier
    25662415
    Citation
    Prestmo A, Hagen G, Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Lydersen S, Halsteinli V, Saltnes T, Lamb SE, Johnsen LG, Saltvedt I. Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial. Lancet. 2015 Apr 25;385(9978):1623-33. doi: 10.1016/S0140-6736(14)62409-0. Epub 2015 Feb 5.
    Results Reference
    result
    PubMed Identifier
    26637222
    Citation
    Taraldsen K, Thingstad P, Sletvold O, Saltvedt I, Lydersen S, Granat MH, Chastin S, Helbostad JL. The long-term effect of being treated in a geriatric ward compared to an orthopaedic ward on six measures of free-living physical behavior 4 and 12 months after a hip fracture - a randomised controlled trial. BMC Geriatr. 2015 Dec 4;15:160. doi: 10.1186/s12877-015-0153-6.
    Results Reference
    result
    PubMed Identifier
    28851773
    Citation
    Haugan K, Johnsen LG, Basso T, Foss OA. Mortality and readmission following hip fracture surgery: a retrospective study comparing conventional and fast-track care. BMJ Open. 2017 Aug 29;7(8):e015574. doi: 10.1136/bmjopen-2016-015574.
    Results Reference
    result
    PubMed Identifier
    26370827
    Citation
    Thingstad P, Taraldsen K, Saltvedt I, Sletvold O, Vereijken B, Lamb SE, Helbostad JL. The long-term effect of comprehensive geriatric care on gait after hip fracture: the Trondheim Hip Fracture Trial--a randomised controlled trial. Osteoporos Int. 2016 Mar;27(3):933-942. doi: 10.1007/s00198-015-3313-9. Epub 2015 Sep 14.
    Results Reference
    result
    PubMed Identifier
    34766330
    Citation
    Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
    Results Reference
    derived
    PubMed Identifier
    23902933
    Citation
    Taraldsen K, Sletvold O, Thingstad P, Saltvedt I, Granat MH, Lydersen S, Helbostad JL. Physical behavior and function early after hip fracture surgery in patients receiving comprehensive geriatric care or orthopedic care--a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2014 Mar;69(3):338-45. doi: 10.1093/gerona/glt097. Epub 2013 Jul 31.
    Results Reference
    derived

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    A New Clinical Pathway for Patients With Fractured Neck of Femur

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