The Effect of a Pre- and Postoperative Orthogeriatric Service

Not Applicable

Completed

• Conditions: Dementia; Delirium

• Registration Number: NCT01009268
• Lead Sponsor: Ullevaal University Hospital

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Primary Completion: 2012-05
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Markers of bone turnover	4 months
Micronutrients in blood	4 months
Activities of Daily Living (ADL) Scale	4 and 12 months
Nottingham Extended Activities of Daily Living (NEADL) scale	4 and 12 months
Intrahospital mortality	4 and 12 months
Cumulative mortality	4 and 12 months
The Short Physical Performance Battery (SPPB) scale	4 and 12 months
Pre-/postoperative delirium	4 and 12 months
Duration/Severity of delirium	4 and 12 months
Other complications	4 and 12 months
Incidence of dementia 12 months postoperatively	4 and 12 months
Length of hospital stay	4 and 12 months

Trial Locations

Locations (1)

Oslo University Hospital, Ullevaal; 🇳🇴 Oslo, Norway