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The Effect of a Pre- and Postoperative Orthogeriatric Service

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01009268
Enrollment
332
Registered
2009-11-06
Start date
2009-09-30
Completion date
2012-12-31
Last updated
2013-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Dementia

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.

Interventions

PROCEDUREOrthogeriatric 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.

Sponsors

The Research Council of Norway
CollaboratorOTHER
Ullevaal University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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)4 and 12 months

Secondary

MeasureTime frame
Nottingham Extended Activities of Daily Living (NEADL) scale4 and 12 months
Intrahospital mortality4 and 12 months
Cumulative mortality4 and 12 months
The Short Physical Performance Battery (SPPB) scale4 and 12 months
Pre-/postoperative delirium4 and 12 months
Activities of Daily Living (ADL) Scale4 and 12 months
Other complications4 and 12 months
Incidence of dementia 12 months postoperatively4 and 12 months
Length of hospital stay4 and 12 months
Markers of bone turnover4 months
Micronutrients in blood4 months
Duration/Severity of delirium4 and 12 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026