Improving treatment for pelvic fragility fractures

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

This study is trying to see if a new treatment plan can help people with pelvic fragility fractures recover better and faster by using proven methods and early diagnosis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 393 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Locations: 8 sites (Almere Stad, Flevoland and 7 other locations)
• Trial ID: NCT06054165 on ClinicalTrials.gov

What this trial studies

This study aims to implement a clinical pathway for patients with pelvic fragility fractures, which are often associated with high morbidity and mortality. By utilizing evidence-based treatment strategies, including early diagnosis and minimally invasive procedures, the study seeks to standardize care for this vulnerable population. The goal is to enhance patient outcomes by addressing the multifactorial risks that contribute to poor recovery. Patients will be recruited from emergency rooms and outpatient clinics of participating hospitals.

Who should consider this trial

Good fit: Ideal candidates are patients who have sustained a pelvic fragility fracture from low-energy trauma and are being treated at a participating hospital.

Not a fit: Patients with pelvic fractures due to malignant tumors or those unable to follow treatment instructions due to severe cognitive decline will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery and reduce complications for patients with pelvic fragility fractures.

How similar studies have performed: While there is limited data on the specific implementation of clinical pathways for pelvic fragility fractures, similar approaches in other areas of trauma care have shown promising results.

Eligibility criteria

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

Where this trial is running

Almere Stad, Flevoland and 7 other locations

• Flevoziekenhuis — Almere Stad, Flevoland, Netherlands (RECRUITING)
• Noordwest Ziekenhuisgroep — Alkmaar, North Holland, Netherlands (RECRUITING)
• BovenIJ ziekenhuis — Amsterdam, North Holland, Netherlands (RECRUITING)
• OLVG — Amsterdam, North Holland, Netherlands (RECRUITING)
• Amsterdam UMC — Amsterdam, North Holland, Netherlands (RECRUITING)
• Spaarne Gasthuis — Haarlem, North Holland, Netherlands (RECRUITING)
• Dijklander Ziekenhuis — Hoorn, North Holland, Netherlands (RECRUITING)
• Zaans Medisch Centrum — Zaandam, North Holland, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Frank W Bloemers, prof — Amsterdam UMC
• Study coordinator: Daphne van Embden, MD, PhD

Conditions: Pelvic Bone Injury, Sacral Fracture, Pelvic Fracture, Fragility Fracture