The Effect of a Pre- and Postoperative Orthogeriatric Service
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|ClinicalTrials.gov Identifier: NCT01009268|
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : May 16, 2013
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 or disease||Intervention/treatment||Phase|
|Dementia Delirium||Procedure: Orthogeriatric intervention||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||332 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||December 2012|
Procedure: Orthogeriatric intervention
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009268
|Oslo University Hospital, Ullevaal|
|Oslo, Norway, 0407 OSLO|
|Study Director:||Torgeir Bruun Wyller, MD, Prof.||University of Oslo, Fac of Med., Geriatric dep.|