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Completed

NCT Number: NCT00667914

A New Clinical Pathway for Patients With Fractured Neck of Femur

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

geriatric work-up

Procedure

Pre- and postoperative treatment of hip-fracture patients in an orthogeriatric unit(geriatric evaluation and management)

Other names: Geriatric work-up in hip-fracture patients

Orthopedic care as usual

Procedure

treatment in ordinary orthopedic unit

Primary outcomes

  1. Mobility

    Time frame: 1, 4 and 12 months after surgery

Secondary outcomes

  1. Site of residence

    Time frame: 1, 4 and 12 months after surgery

  2. Other functional aspects than mobility

    Time frame: 1, 4 and 12 months after surgery

  3. Health economic variables

    Time frame: 1, 4 and 12 months after surgery

  4. Mortality

    Time frame: 1, 4 and 12 months after surgery

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Helse Nord-Trøndelag HF
  • The Research Council of Norway

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 28, 2008
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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