Clinical trial NCT06054165: Impact of a Clinical Pathway for Pelvic Fragility Fractures
Official title: Impact of Regional Implementation of a Clinical Pathway for ELderly Patients With pelVIc Fragility fraCtures (PELVIC); a Multicenter, Stepped-wedge Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Bone Injury
Sacral Fracture
Pelvic Fracture
Fragility Fracture
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Noordwest Ziekenhuisgroep
First posted: 2023-09-26
Enrollment: 393
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster randomized trial
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* Pelvic fragility fracture caused by low energetic trauma
* Patients presented at the emergency room or out-patient clinic of a participating hospital

Exclusion Criteria:

* 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
* Patients who suffer from complications from previous pelvic ring fixation
* Patients with insufficient comprehension of the Dutch language to be able to carry out the physiotherapy instructions for early mobilization

Primary outcomes:
measure: Mobility, using the Parker mobility score (PMS)
timeFrame: Change from baseline PMS at 2 weeks, 3 months, 6 months, and 1 year
Secondary outcomes:
measure: Mobility, using the Elderly mobility scale (EMS)
timeFrame: At 2 weeks, 3 months, and 1 year
measure: Functional performance, using the Katz Index of Independence in Activities of Daily Living (KATZ ADL)
timeFrame: Change from baseline KATZ ADL at 3 months and 1 year
measure: Quality of life, using the EuroQol (EQ-5D-5L) score
timeFrame: Change from baseline EQ-5D-5L at 1 year
measure: Return to home rate
timeFrame: Change from baseline place of residency at 6 weeks, 3 months, 6 months and 1 year
measure: Level of pain, using the Numerical Pain Rating Scale (NRS)
timeFrame: Baseline, one day post-operative (if patient underwent surgery), at 2 weeks, 6 weeks, 3 months and 1 year
measure: Descriptive name and dosage of analgesic medications used
timeFrame: Baseline, 2 weeks, 6 weeks, 3 months, and 1 year
measure: Number of falls after treatment, resulting in additional injury or without injury
timeFrame: At 6 weeks and 3 months
measure: Number of participants with (fracture related) complications
timeFrame: At 2 weeks, 3 months, 6 months, and 1 year
measure: 1-year mortality
timeFrame: At 1 year
measure: 2-year mortality
timeFrame: At 2 year
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
state: Flevoland
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: BovenIJ ziekenhuis
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: OLVG
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
state: Noord-Holland
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC
name: Frank W Bloemers, prof
role: PRINCIPAL_INVESTIGATOR
References: