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 : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture Aged||Procedure: geriatric work-up Procedure: Orthopedic care as usual||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||397 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A New Clinical Pathway for Patients With Fractured Neck of Femur - The Orthopedics Operate, the Geriatricians Manage the Medical Work-up|
|Actual Study Start Date :||April 2008|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||May 2013|
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
- Mobility [ Time Frame: 1, 4 and 12 months after surgery ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667914
|Principal Investigator:||Olav Sletvold, MD. Ph D||Department of Neuroscience, Norwegian University of Science and Technology|