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

A

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

Status

Enrolling

Conditions

Pelvic Fracture
Pelvic Bone Injury
Fragility Fracture
Sacral Fracture

Treatments

Other: Clinical pathway

Study type

Interventional

Funder types

Other

Identifiers

NCT06054165
W22_279

Details and patient eligibility

About

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.

Enrollment

393 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

393 participants in 2 patient groups

Standard-of-care
No Intervention group
Best-practice
Active Comparator group
Treatment:
Other: Clinical pathway

Trial contacts and locations

8

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Central trial contact

Anna H. Mennen, MD; Daphne van Embden, MD, PhD

Data sourced from clinicaltrials.gov

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