A New Clinical Pathway for Patients With Fractured Neck of Femur

This study has been completed.
Sponsor:
Collaborators:
The Research Council of Norway
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00667914
First received: April 18, 2008
Last updated: July 24, 2013
Last verified: July 2013
  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
Aged
Procedure: geriatric work-up
Procedure: Orthopedic care as usual
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A New Clinical Pathway for Patients With Fractured Neck of Femur - The Orthopedics Operate, the Geriatricians Manage the Medical Work-up

Resource links provided by NLM:


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 ]
  • Other functional aspects than mobility [ Time Frame: 1, 4 and 12 months after surgery ] [ Designated as safety issue: No ]
  • Health economic variables [ Time Frame: 1, 4 and 12 months after surgery ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 1, 4 and 12 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 397
Study Start Date: April 2008
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orthogeriatric unit
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)
Other Name: Geriatric work-up in hip-fracture patients
Active Comparator: Orthopedic care as usual
Traditional care in the orthopedic unit
Procedure: Orthopedic care as usual
treatment in 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 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.

  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, pertrochanteric and subtrochanteric hip-fractures

Exclusion Criteria:

  • nursing home residents
  • expected to die within 3 months
  • pathological fractures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667914

Sponsors and Collaborators
Norwegian University of Science and Technology
The Research Council of Norway
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00667914     History of Changes
Other Study ID Numbers: 4.2008.335 (REC)
Study First Received: April 18, 2008
Last Updated: July 24, 2013
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

Additional relevant MeSH terms:
Hip Fractures
Femoral Neck Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 18, 2014