Dementia Clinical Trial
Official title:
The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial
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.
Status | Completed |
Enrollment | 332 |
Est. completion date | December 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital, Ullevaal | Oslo |
Lead Sponsor | Collaborator |
---|---|
Ullevaal University Hospital | The Research Council of Norway |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Activities of Daily Living (ADL) Scale | 4 and 12 months | No | |
Secondary | Nottingham Extended Activities of Daily Living (NEADL) scale | 4 and 12 months | No | |
Secondary | Intrahospital mortality | 4 and 12 months | Yes | |
Secondary | Cumulative mortality | 4 and 12 months | No | |
Secondary | The Short Physical Performance Battery (SPPB) scale | 4 and 12 months | No | |
Secondary | Pre-/postoperative delirium | 4 and 12 months | No | |
Secondary | Duration/Severity of delirium | 4 and 12 months | No | |
Secondary | Other complications | 4 and 12 months | No | |
Secondary | Incidence of dementia 12 months postoperatively | 4 and 12 months | No | |
Secondary | Length of hospital stay | 4 and 12 months | No | |
Secondary | Markers of bone turnover | 4 months | No | |
Secondary | Micronutrients in blood | 4 months | No |
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