Clinical trial NCT01009268: The Effect of a Pre- and Postoperative Orthogeriatric Service
Official title: The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Delirium
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2009-11-06
Enrollment: 332
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 4 and 12 months
Secondary outcomes:
measure: Activities of Daily Living (ADL) Scale
timeFrame: 4 and 12 months
measure: Nottingham Extended Activities of Daily Living (NEADL) scale
timeFrame: 4 and 12 months
measure: Intrahospital mortality
timeFrame: 4 and 12 months
measure: Cumulative mortality
timeFrame: 4 and 12 months
measure: The Short Physical Performance Battery (SPPB) scale
timeFrame: 4 and 12 months
measure: Pre-/postoperative delirium
timeFrame: 4 and 12 months
measure: Duration/Severity of delirium
timeFrame: 4 and 12 months
measure: Other complications
timeFrame: 4 and 12 months
measure: Incidence of dementia 12 months postoperatively
timeFrame: 4 and 12 months
measure: Length of hospital stay
timeFrame: 4 and 12 months
measure: Markers of bone turnover
timeFrame: 4 months
measure: Micronutrients in blood
timeFrame: 4 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevaal
Study officials:
affiliation: University of Oslo, Fac of Med., Geriatric dep.
name: Torgeir Bruun Wyller, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
citation: Torbergsen AC, Watne LO, Frihagen F, Wyller TB, Mowe M. Effects of nutritional intervention upon bone turnover in elderly hip fracture patients. Randomized controlled trial. Clin Nutr ESPEN. 2019 Feb;29:52-58. doi: 10.1016/j.clnesp.2017.11.012. Epub 2018 Oct 30.
citation: Torbergsen AC, Watne LO, Wyller TB, Frihagen F, Stromsoe K, Bohmer T, Mowe M. Micronutrients and the risk of hip fracture: Case-control study. Clin Nutr. 2017 Apr;36(2):438-443. doi: 10.1016/j.clnu.2015.12.014. Epub 2015 Dec 23.
citation: Watne LO, Torbergsen AC, Conroy S, Engedal K, Frihagen F, Hjorthaug GA, Juliebo V, Raeder J, Saltvedt I, Skovlund E, Wyller TB. The effect of a pre- and postoperative orthogeriatric service on cognitive function in patients with hip fracture: randomized controlled trial (Oslo Orthogeriatric Trial). BMC Med. 2014 Apr 15;12:63. doi: 10.1186/1741-7015-12-63.
citation: Wyller TB, Watne LO, Torbergsen A, Engedal K, Frihagen F, Juliebo V, Saltvedt I, Skovlund E, Raeder J, Conroy S. The effect of a pre- and post-operative orthogeriatric service on cognitive function in patients with hip fracture. The protocol of the Oslo Orthogeriatrics Trial. BMC Geriatr. 2012 Jul 20;12:36. doi: 10.1186/1471-2318-12-36.