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Completed

NCT Number: NCT01009268

The Effect of a Pre- and Postoperative Orthogeriatric Service

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Ullevaal

Oslo, 0407 OSLO, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orthogeriatric intervention

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Activities of Daily Living (ADL) Scale

    Time frame: 4 and 12 months

  2. Nottingham Extended Activities of Daily Living (NEADL) scale

    Time frame: 4 and 12 months

  3. Intrahospital mortality

    Time frame: 4 and 12 months

  4. Cumulative mortality

    Time frame: 4 and 12 months

  5. The Short Physical Performance Battery (SPPB) scale

    Time frame: 4 and 12 months

  6. Pre-/postoperative delirium

    Time frame: 4 and 12 months

  7. Duration/Severity of delirium

    Time frame: 4 and 12 months

  8. Other complications

    Time frame: 4 and 12 months

  9. Incidence of dementia 12 months postoperatively

    Time frame: 4 and 12 months

  10. Length of hospital stay

    Time frame: 4 and 12 months

  11. Markers of bone turnover

    Time frame: 4 months

  12. Micronutrients in blood

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 6, 2009
Registry last updated
May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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