Impact of a Clinical Pathway for Pelvic Fragility Fractures (PELVIC)

Impact of Regional Implementation of a Clinical Pathway for ELderly Patients With pelVIc Fragility fraCtures (PELVIC); a Multicenter, Stepped-wedge Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Fracture; Fragility Fracture; Sacral Fracture; Pelvic Bone Injury
• Intervention / Treatment: Other: Clinical pathway

• Study Type: Interventional
• Enrollment (Estimated): 393
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard-of-care
Active Comparator: Best-practice	Other: Clinical pathway; Evidence-based and expert-opinion-based clinical pathway regarding the diagnostic and treatment strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline PMS at 2 weeks, 3 months, 6 months, and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 2 weeks, 3 months, and 1 year
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	Change from baseline KATZ ADL at 3 months and 1 year
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).	Change from baseline EQ-5D-5L at 3 months and 1 year
Return to home rate	The residencies will be grouped in 'living independently at home', 'assisted living', 'nursing home', 'rehabilitation centre', 'palliative care facility'.	Change from baseline place of residency at 3 months, 6 months and 1 year
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.	Baseline, one day post-operative (if patient underwent surgery), at 2 weeks, 6 weeks and 3 months
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.	Baseline, 2 weeks, and 3 months
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.	At 6 weeks and 3 months
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	At 2 weeks, 3 months, 6 months, and 1 year
1-year mortality	Including (presumed) cause of death	At 1 year
2-year mortality	Including (presumed) cause of death	At 2 year

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Noordwest Ziekenhuisgroep

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): May 5, 2025
• Study Completion (Estimated): May 5, 2026

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: W22_279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No