Fragility Fractures of the Pelvis (FFP)

NCT04182776 · tracked via the Priya Life Science Germany tracker

Sponsor

AO Innovation Translation Center

Phase

Observational

Started

2022-03-01

Last updated

2026-07-13

Condition(s) studied

Pelvic Fracture

Study summary

Prospective data will be collected in approximately 420 patients, above the age of 65, suffering from an FFP type fracture equal to or higher than type II, according to Rommens and Hofmann.

Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s, radiological outcomes, and anticipated or procedure-related adverse events (i.e. complications).

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age 65 years or older at time of injury * Diagnosis, via CT scan as per standard of care, of FFP grade II or higher according to the Rommens and Hofmann classification (including fractures of the anterior pelvic ring involving the anterior lip of the acetabulum not regarded as the acetabular fractures) * Informed consent obtained, ie: * Ability to understand the content of the patient information/ICF * Willingness and ability to participate in the registry according to the standard of care in each clinic * Signed and dated Ethics Committee (EC)/ Institutional Review Board (IRB) approved written informed consent OR * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent Exclusion Criteria: * Pelvic fractures that do not meet the criteria of a fragility fracture (ie, high-energy trauma) * FFP type I fractures * Concomitant fractures of the acetabulum (except anterior lip of the acetabulum, see above) * Pathological fractures (ie, patients with malignant or metastatic diseases of the pelvis, infections) * Concomitant osteoporotic fractures outside of pelvis * Participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the PI the results of the present registry

Primary outcome measure(s)

Demographics — Pre-treatment
Year of birth, Gender, Ethnicity, Height (cm) and Weight (kg) will be combined to report BMI in kg/m\^2
Comorbidities — Pre-treatment
Concomitant diseases will be assessed using the Charlson Comorbidity Index (CCI). This score assesses the comorbidity level by considering both the number and severity of pre-defined comorbid conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates. It is a 17-items questionnaire with score range from 0 to 37 points. It estimates the 10-year (or shorter) patient survival.
Cognitive status — Pre-treatment
The MiniCog is a 3-minute instrument assessing cognitive impairment. It consists of two components, a 3-item recall test for memory and a simply scored clock drawing test. A total score ranges from 0 to 5. A score of zero, one or two out of five points in total, indicates a concern in cognitive functioning.
Patient-reported outcomes: PROMIS Pain Interference — from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
PROMIS (Patient-Reported Outcome Measurement Information System) Pain Interference (8 questions) assesses the impact of pain on common activities of daily life including social, cognitive, emotional, physical, and recreational aspects. The higher score represents a higher pain level.
Patient-reported outcomes: PROMIS Physical Function — from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
PROMIS Physical Function (10 questions) assesses self-reported capability of physical activities including instrumental activities of daily living. A higher score indicates a better self-reported capability.
Patient Reported Outcomes - EuroQoL (EQ-5D-3L) — from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
The EQ-5D-3L has five items (mobility, self-care, usual activities, pain/discomfort anxiety/depression) with a three-point categorical response scale level (1 = no problems, 2 = some / moderate problems, 3 = extreme problems) where the patient's current health status is assessed. A unique EQ-5D-3L health state is defined by combining one level from each of the five dimensions. The EQ-5D index score ranges from 0 (death) to 1 (best imaginable quality of life), and negative values express "worse than death" state.

Trial sites (10)

Facility	City	Region
University of Missouri	Columbia	Missouri
The Ottawa Hospital - Civic Campus	Ottawa	Canada
University Medical Center Hamburg Eppendorf	Hamburg	Germany
University Hospital Leipzig	Leipzig	Germany
University Medical Center Johannes Gutenberg-University	Mainz	Germany
Queen Mary Hospital	Hong Kong	Hong Kong
Okayama medical hospital	Okayama	Japan
University Medical Center Groningen	Groningen	Netherlands
Radboud University Medical Center	Nijmegen	Netherlands
Cantonal Hospital Lucerne	Lucerne	Switzerland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04182776 on ClinicalTrials.gov ↗ ← All trials in Germany