Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID06054165

Impact of Regional Implementation of a Clinical Pathway for Elderly Patients With Pelvic Fragility Fractures (PELVIC); a Multicenter, Stepped-wedge Randomized Controlled Trial

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-06-24

393

Participants Needed

8

Research Sites

104 weeks

Total Duration

On this page

Sponsors

A

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

Lead Sponsor

N

Noordwest Ziekenhuisgroep

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pelvic fragility fractures in elderly patients often lead to serious health problems and high death rates. Currently, treatment approaches vary widely due to the lack of a standard protocol. This trial evaluates a new clinical pathway based on evidence and expert experience, aiming to improve outcomes for this vulnerable group who face multiple risks for poor recovery. The study compares the usual care with an evidence-based clinical pathway designed to guide diagnosis and treatment strategies. Patients will be randomly assigned to either continue with standard care or follow this best-practice clinical pathway. The pathway focuses on early diagnosis and minimally invasive treatments tailored for fragile patients. Participants will be monitored over time to assess their mobility, daily function, quality of life, pain levels, medication use, complication rates, and mortality. Assessments use tools like the Parker mobility score, Elderly mobility scale, Katz Index, EuroQol quality of life questionnaire, and pain rating scales. Follow-ups occur at multiple intervals up to two years, with careful tracking of recovery and any additional injuries or complications.

CONDITIONS

Brief Title

Impact of a Clinical Pathway for Pelvic Fragility Fractures

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pelvic fragility fracture caused by low energetic trauma
  • Patients presented at the emergency room or out-patient clinic of a participating hospital
  • Age 50 years or older
Not Eligible

You will not qualify if you...

  • High suspicion of pelvic fracture due to a malignant tumor
  • Severe cognitive decline preventing following instructions (e.g., dementia or Alzheimer's disease)
  • Receiving palliative or terminal care before the injury
  • Wheelchair bound or bedridden before the injury
  • Complications from previous pelvic ring fixation
  • Insufficient comprehension of Dutch to follow physiotherapy instructions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 1 year

Participants follow an evidence-based clinical pathway regarding the diagnostic and treatment strategy for pelvic fragility fractures.

Visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

Trial Site Locations

Total: 8 locations

1

Flevoziekenhuis

Almere Stad, Flevoland, Netherlands, 1315 RA

Actively Recruiting

2

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, Netherlands, 1815 JD

Actively Recruiting

3

BovenIJ ziekenhuis

Amsterdam, North Holland, Netherlands, 1034 CS

Actively Recruiting

4

OLVG

Amsterdam, North Holland, Netherlands, 1061 AE

Actively Recruiting

5

Amsterdam UMC

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

6

Spaarne Gasthuis

Haarlem, North Holland, Netherlands, 2035 RC

Actively Recruiting

7

Dijklander Ziekenhuis

Hoorn, North Holland, Netherlands, 1624 NP

Actively Recruiting

8

Zaans Medisch Centrum

Zaandam, North Holland, Netherlands, 1502 DV

Actively Recruiting

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Research Team

D

Daphne van Embden, MD, PhD

A

Anna H. Mennen, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial.

Anna H M Mennen, Marte Lommerse, Robert Hemke...

https://pubmed.ncbi.nlm.nih.gov/39142675