Full Text View
Tabular View
No Study Results Posted
Related Studies
A New Clinical Pathway for Patients With Fractured Neck of Femur
This study is currently recruiting participants.
Verified by Norwegian University of Science and Technology, March 2009
First Received: April 18, 2008   Last Updated: March 13, 2009   History of Changes
Sponsors and Collaborators: Norwegian University of Science and Technology
The Norwegian Research Council
The Royal Norwegian Ministry of Health
Information provided by: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00667914
  Purpose

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.


Condition Intervention Phase
Hip Fracture
Geriatrics
Procedure: geriatric work-up
Phase II

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A New Clinical Pathway for Patients With Fractured Neck of Femur - The Orthopedics Operate, the Geriatricians Manage the Medical Work-up

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Mobility [ Time Frame: 1, 4 and 12 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Site of residence [ Time Frame: 1, 4 and 12 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Orthogeriatric unit: Experimental
Geriatric work-up on hip-fracture patients
Procedure: geriatric work-up
Pre- and postoperative treatment of hip-fracture patients in an orthogeriatric unit(geriatric evaluation and management) compared to treatment in an ordinary orthopedic unit.
Orthopedic unit: No Intervention
Traditional orthopedic care
Procedure: geriatric work-up
Pre- and postoperative treatment of hip-fracture patients in an orthogeriatric unit(geriatric evaluation and management) compared to treatment in an ordinary 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 and place of residence. As secondary endpoints other relevant functional aspects, 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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • nursing home residents
  • expected to die within 3 months
  • pathological fractures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667914

Contacts
Contact: Olav Sletvold 47-91-567-834 olav.sletvold@ntnu.no
Contact: pernille Thingstad 47-72-575-826 pernille.thingstad@ntnu.no

Locations
Norway
St.Olav University Hospital Recruiting
Trondheim, Norway, 7040
Contact: Pernille Thingstad, PT     47-72-575-826     pernille.thingstad@ntnu.no    
Contact: Olav Sletvold, MD Ph D     47-91-567-834     olav.sletvold@ntnu.no    
Sponsors and Collaborators
Norwegian University of Science and Technology
The Norwegian Research Council
The Royal Norwegian Ministry of Health
Investigators
Principal Investigator: Olav Sletvold, MD. Ph D Department of Neuroscience, Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Department of Neuroscience, Norwegian University of Science and Technology ( Olav Sletvold/professor, dr. med )
Study ID Numbers: 4.2008.335 (REC)
Study First Received: April 18, 2008
Last Updated: March 13, 2009
ClinicalTrials.gov Identifier: NCT00667914     History of Changes
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Hip-unit
Geriatric care
Mobility
Site of residence

Study placed in the following topic categories:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on May 07, 2009