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The Effect of a Pre- and Postoperative Orthogeriatric Service

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01009268
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : May 16, 2013
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Oslo University Hospital ( Ullevaal University Hospital )

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 6, 2009
Last Update Posted Date May 16, 2013
Study Start Date  ICMJE September 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) [ Time Frame: 4 and 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
  • Activities of Daily Living (ADL) Scale [ Time Frame: 4 and 12 months ]
  • Nottingham Extended Activities of Daily Living (NEADL) scale [ Time Frame: 4 and 12 months ]
  • Intrahospital mortality [ Time Frame: 4 and 12 months ]
  • Cumulative mortality [ Time Frame: 4 and 12 months ]
  • The Short Physical Performance Battery (SPPB) scale [ Time Frame: 4 and 12 months ]
  • Pre-/postoperative delirium [ Time Frame: 4 and 12 months ]
  • Duration/Severity of delirium [ Time Frame: 4 and 12 months ]
  • Other complications [ Time Frame: 4 and 12 months ]
  • Incidence of dementia 12 months postoperatively [ Time Frame: 4 and 12 months ]
  • Length of hospital stay [ Time Frame: 4 and 12 months ]
  • Markers of bone turnover [ Time Frame: 4 months ]
  • Micronutrients in blood [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
  • Activities of Daily Living (ADL) Scale [ Time Frame: 4 and 12 months ]
  • Nottingham Extended Activities of Daily Living (NEADL) scale [ Time Frame: 4 and 12 months ]
  • Intrahospital mortality [ Time Frame: 4 and 12 months ]
  • Cumulative mortality [ Time Frame: 4 and 12 months ]
  • The Short Physical Performance Battery (SPPB) scale [ Time Frame: 4 and 12 months ]
  • Pre-/postoperative delirium [ Time Frame: 4 and 12 months ]
  • Duration/Severity of delirium [ Time Frame: 4 and 12 months ]
  • Other complications [ Time Frame: 4 and 12 months ]
  • Incidence of dementia 12 months postoperatively [ Time Frame: 4 and 12 months ]
  • Length of hospital stay [ Time Frame: 4 and 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of a Pre- and Postoperative Orthogeriatric Service
Official Title  ICMJE The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial
Brief Summary

The investigators' aim is to assess the effect of a model of preoperative as well as early postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a single-blind randomised study.

The investigators' main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome.

Detailed Description

The study will be carried out in close cooperation between the Orthopaedic Centre and the Department of Geriatric Medicine. The patients will be randomized in the Emergency Department in accordance with procedures already established for a recently finished trial. The intervention group will be transferred as soon as possible to the orthogeriatric ward, stabilised there preoperatively, and transferred back to the same ward postoperatively for further treatment and rehabilitation, while the control group will be treated in a traditional orthopaedic ward. Operative and anaesthesiologic procedures will be the same in the two groups.

The primary endpoint is chosen in order to optimize clinical relevance as well as sensitivity to change within a wide range of functional performance, and will be recorded four months after the fracture. Our main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome. Accordingly, we will use a composite endpoint tapping cognitive functioning in the lower as well as the higher spectre of performance by these two instruments:

  • Clinical Dementia Rating Scale (CDR), proxy-based scale for severity of dementia, that is able to detect differences also between patients with severe dementia. The scale consists of six questions, each rated 0-3, adding up to a sumscore of 0-18 ("sum of boxes"). The scale is frequently used in dementia treatment trials, and is shown to be valid and reliable. CDR will be scored based on the best available source (relative, staff in nursing home or home nursing service)
  • The 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD). This test is shown to be sensitive for memory changes in persons that have a good or fairly good cognitive functioning. We will use the immediate recall and the delayed recall parts of this task, i.e. two scales.

The primary endpoint will be assessed after four months, by a specially trained research assistant blinded to allocation. The patients will be re-assessed after 12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dementia
  • Delirium
Intervention  ICMJE Procedure: Orthogeriatric intervention
The intervention group will be transferred as soon as possible to the orthogeriatric ward, stabilised there preoperatively, and transferred back to the same ward postoperatively for further treatment and rehabilitation, while the control group will be treated in a traditional orthopaedic ward. Operative and anaesthesiologic procedures will be the same in the two groups.Clinical routines for the orthogeriatric service has been developed during the pilot phase in 2008 and 2009, and are documented in the electronic library of clinical handbooks at Department of Geriatric Medicine.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2013)
332
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2009)
400
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

• Eligible patients will be admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture.

Exclusion Criteria:

  • Hip fracture as part of multi-trauma or high energy trauma (defined as a fall from a higher level than 1 metre). One recent fracture in addition to the hip fracture (e.g. radius or shoulder) is acceptable.
  • Regarded as moribund at admittance.
  • Absence of a valid informed consent or assent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01009268
Other Study ID Numbers  ICMJE 1361
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oslo University Hospital ( Ullevaal University Hospital )
Study Sponsor  ICMJE Ullevaal University Hospital
Collaborators  ICMJE The Research Council of Norway
Investigators  ICMJE
Study Director: Torgeir Bruun Wyller, MD, Prof. University of Oslo, Fac of Med., Geriatric dep.
PRS Account Oslo University Hospital
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP