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A New Clinical Pathway for Patients With Fractured Neck of Femur

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ClinicalTrials.gov Identifier: NCT00667914
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : December 3, 2019
Sponsor:
Collaborators:
The Research Council of Norway
Central Norway Regional Health Authority
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE April 18, 2008
First Posted Date  ICMJE April 28, 2008
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE April 2008
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2008)
Mobility [ Time Frame: 1, 4 and 12 months after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2010)
  • Site of residence [ Time Frame: 1, 4 and 12 months after surgery ]
  • Other functional aspects than mobility [ Time Frame: 1, 4 and 12 months after surgery ]
  • Health economic variables [ Time Frame: 1, 4 and 12 months after surgery ]
  • Mortality [ Time Frame: 1, 4 and 12 months after surgery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2008)
Site of residence [ Time Frame: 1, 4 and 12 months after surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A New Clinical Pathway for Patients With Fractured Neck of Femur
Official Title  ICMJE A New Clinical Pathway for Patients With Fractured Neck of Femur - The Orthopedics Operate, the Geriatricians Manage the Medical Work-up
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hip Fracture
  • Aged
Intervention  ICMJE
  • Procedure: geriatric work-up
    Pre- and postoperative treatment of hip-fracture patients in an orthogeriatric unit(geriatric evaluation and management)
    Other Name: Geriatric work-up in hip-fracture patients
  • Procedure: Orthopedic care as usual
    treatment in ordinary orthopedic unit
Study Arms  ICMJE
  • Experimental: Orthogeriatric unit
    Geriatric work-up on hip-fracture patients
    Intervention: Procedure: geriatric work-up
  • Active Comparator: Orthopedic care as usual
    Traditional care in the orthopedic unit
    Intervention: Procedure: Orthopedic care as usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2013)
397
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2008)
400
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Norway
 
Administrative Information
NCT Number  ICMJE NCT00667914
Other Study ID Numbers  ICMJE 4.2008.335 (REC)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • The Research Council of Norway
  • Central Norway Regional Health Authority
Investigators  ICMJE
Principal Investigator: Olav Sletvold, MD. Ph D Department of Neuroscience, Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP