A New Clinical Pathway for Patients With Fractured Neck of Femur

Aged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667914
• Other study ID #: 4.2008.335 (REC)
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: May 2013

Study information

• Verified date: December 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Femoral Neck Fractures
• Hip Fracture
• Hip Fractures

Intervention

Procedure:
• geriatric work-up
Pre- and postoperative treatment of hip-fracture patients in an orthogeriatric unit(geriatric evaluation and management)
• Orthopedic care as usual
treatment in ordinary orthopedic unit

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Central Norway Regional Health Authority, The Research Council of Norway

References & Publications (6)

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. — View 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 — View 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. — View 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. — View 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 af — View 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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility		1, 4 and 12 months after surgery
Secondary	Site of residence		1, 4 and 12 months after surgery
Secondary	Other functional aspects than mobility		1, 4 and 12 months after surgery
Secondary	Health economic variables		1, 4 and 12 months after surgery
Secondary	Mortality		1, 4 and 12 months after surgery