Back to resultsImpact of a Clinical Pathway for Pelvic Fragility Fractures (PELVIC)
Primary Purpose
Pelvic Bone Injury, Sacral Fracture, Pelvic Fracture
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical pathway
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Bone Injury
Eligibility Criteria
Inclusion Criteria: Unilateral or bilateral sacral, iliac, ramus superior and/or ramus inferior fracture Pelvic 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard-of-care
Best-practice
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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).
Return to home rate
The residencies will be grouped in 'living independently at home', 'assisted living', 'nursing home', 'rehabilitation centre', 'palliative care facility'.
Level of pain, using the Numerical Pain Rating Scale (NRS)
The Numerical Pain Rating Scale is an aspecific measurement tool from 0-10, with 0 reflecting no pain, 1-4 mild pain, 5-7 moderate pain, and 7-10 severe pain. This tool is currently already used by nurses in all hospitals in the Netherlands.
Descriptive name and dosage of analgesic medications used
All analgesic medication that the patient is given will be recorded, and compared to the analgesic medication that the patient used prior to injury.
Number of falls after treatment, resulting in additional injury or without injury
The investigators will differentiate between 'serious falls', defined as falls where the patient gets injured, and 'minor falls' where the patient did not get injured. The investigators will ask the patients during follow-up at the out-patient clinic if they fell since the last visit. The frequency of falling is related to an increased risk of mortality in elderly patients.
Number of participants with (fracture related) complications
This includes general complications tot may occur during a period of reduced mobility or hospital admission (such as pneumonia, urinary tract infection, thromboembolic event, heart failure, cerebrovascular event, myocardial infarction). Complications related to operative treatment will also be recorded. These complications include but are not limited to: re-operation, delayed operation, infection, screw back out, malposition of screw, neurological damage. All complications will be categorized for level of severity and the necessity for further treatment according to the Clavien-Dindo classification
1-year mortality
Including (presumed) cause of death
2-year mortality
Including (presumed) cause of death
Full Information
NCT ID
NCT06054165
First Posted
March 21, 2023
Last Updated
September 26, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Noordwest Ziekenhuisgroep
1. Study Identification
Unique Protocol Identification Number
NCT06054165
Brief Title
Impact of a Clinical Pathway for Pelvic Fragility Fractures
Acronym
PELVIC
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
May 5, 2025 (Anticipated)
Study Completion Date
May 5, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Noordwest Ziekenhuisgroep
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Bone Injury, Sacral Fracture, Pelvic Fracture, Fragility Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Stepped-wedge cluster randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
393 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard-of-care
Arm Type
No Intervention
Arm Title
Best-practice
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Clinical pathway
Intervention Description
Evidence-based and expert-opinion-based clinical pathway regarding the diagnostic and treatment strategy
Primary Outcome Measure Information:
Title
Mobility, using the Parker mobility score (PMS)
Description
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 year
Secondary Outcome Measure Information:
Title
Mobility, using the Elderly mobility scale (EMS)
Description
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 year
Title
Functional performance, using the Katz Index of Independence in Activities of Daily Living (KATZ ADL)
Description
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 year
Title
Quality of life, using the EuroQol (EQ-5D-5L) score
Description
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 3 months and 1 year
Title
Return to home rate
Description
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 3 months, 6 months and 1 year
Title
Level of pain, using the Numerical Pain Rating Scale (NRS)
Description
The Numerical Pain Rating Scale is an aspecific measurement tool from 0-10, with 0 reflecting no pain, 1-4 mild pain, 5-7 moderate pain, and 7-10 severe pain. This tool is currently already used by nurses in all hospitals in the Netherlands.
Time Frame
Baseline, one day post-operative (if patient underwent surgery), at 2 weeks, 6 weeks and 3 months
Title
Descriptive name and dosage of analgesic medications used
Description
All analgesic medication that the patient is given will be recorded, and compared to the analgesic medication that the patient used prior to injury.
Time Frame
Baseline, 2 weeks, and 3 months
Title
Number of falls after treatment, resulting in additional injury or without injury
Description
The investigators will differentiate between 'serious falls', defined as falls where the patient gets injured, and 'minor falls' where the patient did not get injured. The investigators will ask the patients during follow-up at the out-patient clinic if they fell since the last visit. The frequency of falling is related to an increased risk of mortality in elderly patients.
Time Frame
At 6 weeks and 3 months
Title
Number of participants with (fracture related) complications
Description
This includes general complications tot may occur during a period of reduced mobility or hospital admission (such as pneumonia, urinary tract infection, thromboembolic event, heart failure, cerebrovascular event, myocardial infarction). Complications related to operative treatment will also be recorded. These complications include but are not limited to: re-operation, delayed operation, infection, screw back out, malposition of screw, neurological damage. All complications will be categorized for level of severity and the necessity for further treatment according to the Clavien-Dindo classification
Time Frame
At 2 weeks, 3 months, 6 months, and 1 year
Title
1-year mortality
Description
Including (presumed) cause of death
Time Frame
At 1 year
Title
2-year mortality
Description
Including (presumed) cause of death
Time Frame
At 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral or bilateral sacral, iliac, ramus superior and/or ramus inferior fracture
Pelvic 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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose
Learn more about this trial
Impact of a Clinical Pathway for Pelvic Fragility Fractures
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