A New Clinical Pathway for Patients With Fractured Neck of Femur

• ClinicalTrials.gov Identifier: NCT00667914
• Recruitment Status: Completed
• First Posted: April 28, 2008
• Last Update Posted: December 3, 2019
• Sponsor: Norwegian University of Science and Technology
• Collaborators: The Research Council of Norway; Central Norway Regional Health Authority
• Information provided by (Responsible Party): Norwegian University of Science and Technology

Tracking Information

• First Submitted Date: April 18, 2008
• First Posted Date: April 28, 2008
• Last Update Posted Date: December 3, 2019
• Actual Study Start Date: April 2008
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 25, 2008): Mobility [ Time Frame: 1, 4 and 12 months after surgery ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 22, 2010)

• 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 ]

• Original Secondary Outcome Measures (submitted: April 25, 2008): Site of residence [ Time Frame: 1, 4 and 12 months after surgery ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Hip Fracture
• Aged

Intervention

• 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
• Procedure: Orthopedic care as usual
  treatment in ordinary orthopedic unit

Study Arms

• Experimental: Orthogeriatric unit
  Geriatric work-up on hip-fracture patients
  Intervention: Procedure: geriatric work-up
• Active Comparator: Orthopedic care as usual
  Traditional care in the orthopedic unit
  Intervention: Procedure: Orthopedic care as usual

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 24, 2013): 397
• Original Estimated Enrollment (submitted: April 25, 2008): 400
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 70 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Norway

Administrative Information

• NCT Number: NCT00667914
• Other Study ID Numbers: 4.2008.335 (REC)
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Norwegian University of Science and Technology
• Study Sponsor: Norwegian University of Science and Technology

Collaborators

• The Research Council of Norway
• Central Norway Regional Health Authority

Investigators

• Principal Investigator: Olav Sletvold, MD. Ph D; Department of Neuroscience, Norwegian University of Science and Technology

• PRS Account: Norwegian University of Science and Technology
• Verification Date: December 2019