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NCT Number: NCT06054165

Impact of a Clinical Pathway for Pelvic Fragility Fractures

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flevoziekenhuis, Almere Stad, Flevoland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Pathway

Other

Evidence-based and expert-opinion-based clinical pathway regarding the diagnostic and treatment strategy

Primary outcomes

  1. Mobility, using the Parker mobility score (PMS)

    Time frame: Change from baseline PMS at 2 weeks, 3 months, 6 months, and 1 year

    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 outcomes

  1. Mobility, using the Elderly mobility scale (EMS)

    Time frame: At 2 weeks, 3 months, and 1 year

    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.

  2. Functional performance, using the Katz Index of Independence in Activities of Daily Living (KATZ ADL)

    Time frame: Change from baseline KATZ ADL at 3 months and 1 year

    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

  3. Quality of life, using the EuroQol (EQ-5D-5L) score

    Time frame: Change from baseline EQ-5D-5L at 1 year

    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).

  4. Return to home rate

    Time frame: Change from baseline place of residency at 6 weeks, 3 months, 6 months and 1 year

    The residencies will be grouped in 'living independently at home', 'assisted living', 'nursing home', 'rehabilitation centre', 'palliative care facility'.

  5. Level of pain, using the Numerical Pain Rating Scale (NRS)

    Time frame: Baseline, one day post-operative (if patient underwent surgery), at 2 weeks, 6 weeks, 3 months and 1 year

    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.

  6. Descriptive name and dosage of analgesic medications used

    Time frame: Baseline, 2 weeks, 6 weeks, 3 months, and 1 year

    All analgesic medication that the patient is given will be recorded, and compared to the analgesic medication that the patient used prior to injury. The medication will be categorized according to the World Health Organisation analgesic ladder to facilitate comparison of changes in patients' analgesic medication usage.

  7. Number of falls after treatment, resulting in additional injury or without injury

    Time frame: At 6 weeks and 3 months

    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.

  8. Number of participants with (fracture related) complications

    Time frame: At 2 weeks, 3 months, 6 months, and 1 year

    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

  9. 1-year mortality

    Time frame: At 1 year

    Including (presumed) cause of death

  10. 2-year mortality

    Time frame: At 2 year

    Including (presumed) cause of death

Study contacts

Contact information is provided by the study sponsor or research team.

Anna H. Mennen, MD

CONTACT

[email protected]

020 - 566 9111

Daphne van Embden, MD, PhD

CONTACT

[email protected]

020-566 9111

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Noordwest Ziekenhuisgroep

Registry information

Official study title

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

Acronym: PELVIC

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Sep 26, 2023
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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