Impact of a Clinical Pathway for Pelvic Fragility Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence of these injuries, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practice. New insights in treatment strategies, such as early diagnosis and minimal invasive operative treatment of these fragile patient population, has led to the development of several clinical pathways in recent literature. The aim of this study is to implement an evidence and experience-based treatment clinical pathway to improve the outcomes in this fragile patient population that currently has multifactorial risks for poor outcome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pelvic fragility fracture caused by low energetic trauma
Patients presented at the emergency room or out-patient clinic of a participating hospital
Disqualifiers
Patients with high suspicion of a pelvic fracture due to a malignant tumor
Patients who are unable to follow instructions due to severe cognitive decline (for example due to dementia or Alzheimer's disease)
Patients who pre-trauma received palliative or terminal care
Patients who pre-trauma were wheelchair bound or bedridden
Trial design
Design model
Crossover
Treatments tested in this trial
Clinical pathway
Other interventionEvidence-based and expert-opinion-based clinical pathway regarding the diagnostic and treatment strategy
Treatment groups
393 Participants
are divided into 2 treatment groupsGroup A: Standard-of-careNo intervention 0 interventions
Group B: Best-practiceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mobility, using the Parker mobility score (PMS)
Since there is no validated tool to measure mobility specifically after a pelvic fracture, the investigators choose to use The Parker mobility score as a primary outcome measurement. The Parker mobility score is a valid and reliable score measuring mobility in hip fracture patients. The Parker Mobility Score answers three questions, each valued 0-3 points, and is commonly used in clinical practice to monitor the mobility of geriatric patients. A score of 0-3 is considered low, 4-6 moderate, and 7-9 reflects good mobility. Furthermore, the Parker Mobility Score is a validated assessment tool for mortality in patients with reduced mobility after hip surgery.
Time frame
Change from baseline PMS at 2 weeks, 3 months, 6 months, and 1 yearSecondary outcomes
1
Mobility, using the Elderly mobility scale (EMS)
The Elderly Mobility Scale is a 20 point validated assessment tool to evaluate mobility specifically in elderly patients. The investigators decided, despite the fact that this tool has an element of measurement in it which makes it harder to determine the pre-injury score, to add this tool since it does a better job distinguishing between patients who are able to sit up and go from sitting to standing. The Elderly mobility scale ranges from 0-20 points, with high scores representing better outcome than low scores.
Time frame
At 2 weeks, 3 months, and 1 year2
Functional performance, using the Katz Index of Independence in Activities of Daily Living (KATZ ADL)
This index is one of the most commonly used scores to measure the functional status of elderly individuals. It assesses the activities of daily living using six questions, each valued 0 or 1. The score ranges from 0-6, and a score of 6 indicates full function while 4 indicates moderate impairment, and 2 or less indicates severe functional impairment
Time frame
Change from baseline KATZ ADL at 3 months and 1 year3
Quality of life, using the EuroQol (EQ-5D-5L) score
The EQ-5D-5L is a generic quality of life questionnaire which consists of a visual analogue scale and five questions about mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each question has three answer alternatives, with 1 indicating the optimal health state and 5 indicating severe problems. There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).
Time frame
Change from baseline EQ-5D-5L at 1 year4
Return to home rate
The residencies will be grouped in 'living independently at home', 'assisted living', 'nursing home', 'rehabilitation centre', 'palliative care facility'.
Time frame
Change from baseline place of residency at 6 weeks, 3 months, 6 months and 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Noordwest Ziekenhuisgroep
Collaborator
Source ClinicalTrials.gov