Impact of a Clinical Pathway for Pelvic Fragility Fractures

NCT06054165 | Recruiting

• 1 other identifier: W22_279
• Study Type: interventional
• Target: 393
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Pelvic Bone Injury; Sacral Fracture; Pelvic Fracture; Fragility Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Mobility, using the Elderly mobility scale (EMS)

  At 2 weeks, 3 months, and 1 year

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

  Change from baseline KATZ ADL at 3 months and 1 year

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

  Change from baseline EQ-5D-5L at 1 year

• Return to home rate

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

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

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

Study Arms (2)

Standard-of-care

NO INTERVENTION

Best-practice

ACTIVE COMPARATOR

Other: Clinical pathway

Interventions

Clinical pathway OTHER

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

Best-practice

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pelvic fragility fracture caused by low energetic trauma
• Patients presented at the emergency room or out-patient clinic of a participating hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Noordwest Ziekenhuisgroep: collaborator

Study Sites (8)

Flevoziekenhuis

Almere Stad, Flevoland, 1315 RA, Netherlands

RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, 1815 JD, Netherlands

RECRUITING

BovenIJ ziekenhuis

Amsterdam, North Holland, 1034 CS, Netherlands

RECRUITING

OLVG

Amsterdam, North Holland, 1061 AE, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Spaarne Gasthuis

Haarlem, North Holland, 2035 RC, Netherlands

RECRUITING

Dijklander Ziekenhuis

Hoorn, North Holland, 1624 NP, Netherlands

RECRUITING

Zaans Medisch Centrum

Zaandam, North Holland, 1502 DV, Netherlands

RECRUITING

Related Publications (1)

• Mennen AHM, Lommerse M, Hemke R, Willems HC, Maas M, Bloemers FW, Ponsen KJ, Van Embden D. 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. BMJ Open. 2024 Aug 13;14(8):e083809. doi: 10.1136/bmjopen-2023-083809.

  PMID: 39142675 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Frank W Bloemers, prof

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne van Embden, MD, PhD

CONTACT

020-566 9111; d.vanembden@amsterdamumc.nl

Anna H. Mennen, MD

CONTACT

020 - 566 9111; a.h.mennen@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stepped-wedge cluster randomized trial

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: September 26, 2023
• Study Start: January 21, 2024
• Primary Completion: April 27, 2025
• Study Completion (Estimated): April 27, 2027
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose

Locations

NL (8)