To investigate the effect of a GFC regarding major adverse events (AE) with a relationship to the treatment / residential status / immobilization (as defined under "Primary outcome measures") from surgery to a 36 month follow-up.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Smaller proportion of patients with at least one major AE related to treatment
/ residential status / immobilization (as defined below) in the GFC group
compared to the UCC group.
AEs related to treatment / residential status / immobilization include and are
limited to:
- Delirium
- Congestive heart failure
*- Pneumonia
*- Deep venous thrombosis
*- Pulmonary embolism
*- Pressure ulcers
*- Myocardial infarction
*
Secondary outcome
- Any other AE not mentioned under primary measure(s) as well as its
relationship to the treatment /residential status / immobilization
*- Activities of daily living
o Modified Barthel index pre-injury, at12 weeks and 12 months
*- Number of re-admissions to an acute hospital
*- Mobility
o Timedupandgotest(TUG) at 12 weeks and12 months
o Parker Mobility Score pre-injury, at 12 weeks and 12 months
*- Number of falls
*- Pain using a Numeric Rating Scale
*- Residential status pre-injury, at discharge, at 12 weeks and 12 months
*- Quality-of-life
o EQ-5D questionnaire at 12 weeks and 12 months
*- Mortality
*- Time from admission to start of pain medication management
*- Time from admission to start of fluid management
*- Time from admission to surgery
*- Time from surgery to discharge
- Number of patients receiving adequate secondary fracture prevention medication
*- Medication
o Number of different types of medication at admission, discharge 1, 12
weeks, 12 months
o Information whether analgesics, osteoporosis and other medications are
administered at all study visit time points
*- Number of patients for which the nutrition status was evaluated / adapted
- Occurrence of a contralateral hip fracture
*- Direct and indirect costs
Background summary
The number of geriatric trauma patients is rapidly increasing. Fragility
fractures and their care are a challenge to health care systems and societies.
In 1990, the WHO estimated a worldwide occurrence of 1.3*1.6 million
osteoporotic hip fractures and predicted an increase to 4 million per year by
2025, with the largest number occurring in Asia. Because of multiple
comorbidities, treatment of geriatric fracture patients showed to be associated
with a high number of complications. Different ortho-geriatric concepts have
been developed to improve patient*s outcome. Until now, the beneficial effect
of these models could not be proven. There are great costs related to geriatric
trauma. The current care is often sub-optimal. Fracture services often fail to
respond to the true complexity of their older patients* needs * for detailed
medical and rehabilitation care as well as surgery.
The scope of a geriatric co-management program is to improve both the quality
and cost-effectiveness of fracture treatment in geriatric patients. Care
pathways and co-management of geriatric hip fracture patients need to be
further evaluated in order to demonstrate the effect of interdisciplinary
geriatric interventions identification of such patients who need specific
medical or multidisciplinary attention.
Study objective
To investigate the effect of a GFC regarding major adverse events (AE) with a
relationship to the treatment / residential status / immobilization (as defined
under "Primary outcome measures") from surgery to a 36 month follow-up.
Study design
Prospective multicenter cohort observational study
Study burden and risks
The risk of specific complications during participation of the study is low,
despite the high number of complications during standard treatment. The study
comprises a registration and data management so no risks are involved in
participating in the trial itself. No additional ionizing radiation is
necessary, as the follow-up visits are standard of care. It is expected that
added measurements in this study will take 2 times 15 minutes and a telephone
call at 3 years of 10 minutes.
Stettbachstrasse 6
Duebendorf 8600
CH
Stettbachstrasse 6
Duebendorf 8600
CH
Listed location countries
Age
Inclusion criteria
Preoperative Inclusion Criteria:
Age * 70 years
Geriatric patients with hip fractures Treated either with Osteosynthesis or Endoprosthesis
Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form
Signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved written informed consent
Exclusion criteria
Preoperative Exclusion Criteria:
Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
Prisoner
Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02297581 |
| CCMO | NL52759.068.15 |