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The Effect of a Pre- and Postoperative Orthogeriatric Service

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Oslo University Hospital ( Ullevaal University Hospital )
ClinicalTrials.gov Identifier:
NCT01009268
First received: November 5, 2009
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Dementia
Delirium
Procedure: Orthogeriatric intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Activities of Daily Living (ADL) Scale [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Nottingham Extended Activities of Daily Living (NEADL) scale [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Intrahospital mortality [ Time Frame: 4 and 12 months ] [ Designated as safety issue: Yes ]
  • Cumulative mortality [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • The Short Physical Performance Battery (SPPB) scale [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Pre-/postoperative delirium [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Duration/Severity of delirium [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Other complications [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Incidence of dementia 12 months postoperatively [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Markers of bone turnover [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Micronutrients in blood [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 332
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009268

Locations
Norway
Oslo University Hospital, Ullevaal
Oslo, Norway, 0407 OSLO
Sponsors and Collaborators
Ullevaal University Hospital
The Research Council of Norway
Investigators
Study Director: Torgeir Bruun Wyller, MD, Prof. University of Oslo, Fac of Med., Geriatric dep.
  More Information

Additional Information:
No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital ( Ullevaal University Hospital )
ClinicalTrials.gov Identifier: NCT01009268     History of Changes
Other Study ID Numbers: 1361
Study First Received: November 5, 2009
Last Updated: May 15, 2013
Health Authority: Norway: Regional Committees for Medical and Health Research Ethics

ClinicalTrials.gov processed this record on November 20, 2014