A New Clinical Pathway for Patients With Fractured Neck of Femur
Primary Purpose
Hip Fracture, Aged
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
geriatric work-up
Orthopedic care as usual
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fracture focused on measuring Hip-unit, Geriatric care, Mobility, Site of residence
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Orthogeriatric unit
Orthopedic care as usual
Arm Description
Geriatric work-up on hip-fracture patients
Traditional care in the orthopedic unit
Outcomes
Primary Outcome Measures
Mobility
Secondary Outcome Measures
Site of residence
Other functional aspects than mobility
Health economic variables
Mortality
Full Information
NCT ID
NCT00667914
First Posted
April 18, 2008
Last Updated
December 1, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
The Research Council of Norway, Helse Nord-Trøndelag HF
1. Study Identification
Unique Protocol Identification Number
NCT00667914
Brief Title
A New Clinical Pathway for Patients With Fractured Neck of Femur
Official Title
A New Clinical Pathway for Patients With Fractured Neck of Femur - The Orthopedics Operate, the Geriatricians Manage the Medical Work-up
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 2008 (Actual)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
The Research Council of Norway, Helse Nord-Trøndelag HF
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Aged
Keywords
Hip-unit, Geriatric care, Mobility, Site of residence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orthogeriatric unit
Arm Type
Experimental
Arm Description
Geriatric work-up on hip-fracture patients
Arm Title
Orthopedic care as usual
Arm Type
Active Comparator
Arm Description
Traditional care in the orthopedic unit
Intervention Type
Procedure
Intervention Name(s)
geriatric work-up
Other Intervention Name(s)
Geriatric work-up in hip-fracture patients
Intervention Description
Pre- and postoperative treatment of hip-fracture patients in an orthogeriatric unit(geriatric evaluation and management)
Intervention Type
Procedure
Intervention Name(s)
Orthopedic care as usual
Intervention Description
treatment in ordinary orthopedic unit
Primary Outcome Measure Information:
Title
Mobility
Time Frame
1, 4 and 12 months after surgery
Secondary Outcome Measure Information:
Title
Site of residence
Time Frame
1, 4 and 12 months after surgery
Title
Other functional aspects than mobility
Time Frame
1, 4 and 12 months after surgery
Title
Health economic variables
Time Frame
1, 4 and 12 months after surgery
Title
Mortality
Time Frame
1, 4 and 12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Sletvold, MD. Ph D
Organizational Affiliation
Department of Neuroscience, Norwegian University of Science and Technology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21510886
Citation
Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Prestmo A, Lamb SE, Aamodt A, Johnsen R, Magnussen J, Saltvedt I. Effect of in-hospital comprehensive geriatric assessment (CGA) in older people with hip fracture. The protocol of the Trondheim Hip Fracture trial. BMC Geriatr. 2011 Apr 21;11:18. doi: 10.1186/1471-2318-11-18.
Results Reference
background
PubMed Identifier
26895846
Citation
Prestmo A, Saltvedt I, Helbostad JL, Taraldsen K, Thingstad P, Lydersen S, Sletvold O. Who benefits from orthogeriatric treatment? Results from the Trondheim hip-fracture trial. BMC Geriatr. 2016 Feb 19;16:49. doi: 10.1186/s12877-016-0218-1.
Results Reference
background
PubMed Identifier
25662415
Citation
Prestmo A, Hagen G, Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Lydersen S, Halsteinli V, Saltnes T, Lamb SE, Johnsen LG, Saltvedt I. Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial. Lancet. 2015 Apr 25;385(9978):1623-33. doi: 10.1016/S0140-6736(14)62409-0. Epub 2015 Feb 5.
Results Reference
result
PubMed Identifier
26637222
Citation
Taraldsen K, Thingstad P, Sletvold O, Saltvedt I, Lydersen S, Granat MH, Chastin S, Helbostad JL. The long-term effect of being treated in a geriatric ward compared to an orthopaedic ward on six measures of free-living physical behavior 4 and 12 months after a hip fracture - a randomised controlled trial. BMC Geriatr. 2015 Dec 4;15:160. doi: 10.1186/s12877-015-0153-6.
Results Reference
result
PubMed Identifier
28851773
Citation
Haugan K, Johnsen LG, Basso T, Foss OA. Mortality and readmission following hip fracture surgery: a retrospective study comparing conventional and fast-track care. BMJ Open. 2017 Aug 29;7(8):e015574. doi: 10.1136/bmjopen-2016-015574.
Results Reference
result
PubMed Identifier
26370827
Citation
Thingstad P, Taraldsen K, Saltvedt I, Sletvold O, Vereijken B, Lamb SE, Helbostad JL. The long-term effect of comprehensive geriatric care on gait after hip fracture: the Trondheim Hip Fracture Trial--a randomised controlled trial. Osteoporos Int. 2016 Mar;27(3):933-942. doi: 10.1007/s00198-015-3313-9. Epub 2015 Sep 14.
Results Reference
result
PubMed Identifier
34766330
Citation
Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
Results Reference
derived
PubMed Identifier
23902933
Citation
Taraldsen K, Sletvold O, Thingstad P, Saltvedt I, Granat MH, Lydersen S, Helbostad JL. Physical behavior and function early after hip fracture surgery in patients receiving comprehensive geriatric care or orthopedic care--a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2014 Mar;69(3):338-45. doi: 10.1093/gerona/glt097. Epub 2013 Jul 31.
Results Reference
derived
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A New Clinical Pathway for Patients With Fractured Neck of Femur
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