Actively Recruiting
Fragility Fractures of the Pelvis Observational Outcome Study Comparing Surgical and Conservative Treatments
Led by AO Innovation Translation Center · Updated on 2025-12-19
420
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting prospective data on approximately 420 patients aged 65 and older who have suffered fragility fractures of the pelvis (FFP) type II or higher, based on the Rommens and Hofmann classification. This observational study aims to compare patient outcomes and complication rates between surgical and conservative treatments for pelvic fractures with varying levels of instability. All patients will receive standard care as determined by their clinicians, without any intervention dictated by the registry. Treatments will follow routine procedures based on patient characteristics. Patients will be followed for up to one year after their treatment, whether surgical or non-surgical. During the study, data will be collected on the patients' underlying diseases, treatment details, functional status, patient-reported outcomes including pain, physical function, and quality of life, as well as radiological outcomes and any treatment or procedure-related complications. Assessments will occur from before treatment through 12 months after, including measures like PROMIS Pain Interference, PROMIS Physical Function, EuroQoL, Parker Mobility Score, Modified Barthel index, residential status, and mortality tracking.
CONDITIONS
Brief Title
Fragility Fractures of the Pelvis (FFP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older at time of injury
- Diagnosis of fragility fracture of the pelvis grade II or higher by CT scan, according to Rommens and Hofmann classification
- Ability to understand study information and provide informed consent
- Willingness and ability to participate as per clinic standards
- Signed and dated informed consent as approved by ethics committee or institutional review board
You will not qualify if you...
- Pelvic fractures caused by high-energy trauma
- Fragility fracture of the pelvis type I
- Fractures involving the acetabulum, except the anterior lip
- Pathological fractures due to cancer, metastatic disease, or infections
- Other osteoporotic fractures outside the pelvis
- Participation in another medical device or drug study within the past month that could affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months after treatment
Participants who undergo routine care are observed for outcomes including pain, physical function, mobility, residential status, mortality, radiological outcomes, and complications.
Regular assessments during follow-up visits for up to 12 months
Trial Site Locations
Total: 10 locations
1
University of Missouri
Columbia, Missouri, United States, 65203
Actively Recruiting
2
The Ottawa Hospital - Civic Campus
Ottawa, Canada
Actively Recruiting
3
University Medical Center Hamburg Eppendorf
Hamburg, Germany
Actively Recruiting
4
University Hospital Leipzig
Leipzig, Germany
Actively Recruiting
5
University Medical Center Johannes Gutenberg-University
Mainz, Germany, 55131
Actively Recruiting
6
Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
7
Okayama medical hospital
Okayama, Japan
Actively Recruiting
8
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
9
Radboud University Medical Center
Nijmegen, Netherlands
Terminated
10
Cantonal Hospital Lucerne
Lucerne, Switzerland
Actively Recruiting
Research Team
A
Aleksandra Hodor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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