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Sponsors and Collaborators: |
Norwegian University of Science and Technology The Norwegian Research Council The Royal Norwegian Ministry of Health |
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Information provided by: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT00667914 |
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 |
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Hip Fracture Geriatrics |
Procedure: geriatric work-up |
Phase II |
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 |
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 |
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Orthogeriatric unit: Experimental
Geriatric work-up on hip-fracture patients
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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.
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Orthopedic unit: No Intervention
Traditional orthopedic care
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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.
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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.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Olav Sletvold | 47-91-567-834 | olav.sletvold@ntnu.no |
Contact: pernille Thingstad | 47-72-575-826 | pernille.thingstad@ntnu.no |
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 |
Principal Investigator: | Olav Sletvold, MD. Ph D | Department of Neuroscience, Norwegian University of Science and Technology |
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 |
Hip-unit Geriatric care Mobility Site of residence |
Femoral Neck Fractures Hip Fractures Femoral Fractures Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Leg Injuries |
Femoral Neck Fractures Hip Fractures Femoral Fractures Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Leg Injuries Hip Injuries |