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NCT04182776

Fragility Fractures of the Pelvis (FFP)

Active, Not Recruiting
Not specifiedAges 65+Observational
AO Innovation Translation Center
~420 participants
Updated 2026-07-13 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demographics
Measured over Pre-treatment
+5 more outcomes measured

Conditions

Pelvic Fracture

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NCT04182776

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cantonal Hospital Lucerne

    Lucerne, Switzerlandno site contact published

  • Okayama medical hospital

    Okayama, Japanno site contact published

  • Queen Mary Hospital

    Hong Kong, Hong Kongno site contact published

  • Radboud University Medical Center

    Nijmegen, Netherlandsno site contact published

  • The Ottawa Hospital - Civic Campus

    Ottawa, Canadano site contact published

  • University Hospital Leipzig

    Leipzig, Germanyno site contact published

  • University Medical Center Groningen

    Groningen, Netherlandsno site contact published

  • University Medical Center Hamburg Eppendorf

    Hamburg, Germanyno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pol Maria Rommens, MD · PRINCIPAL_INVESTIGATOR · University Medical Center Johannes Gutenberg-University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • DemographicsPre-treatment

    Year of birth, Gender, Ethnicity, Height (cm) and Weight (kg) will be combined to report BMI in kg/m\^2

  • ComorbiditiesPre-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 statusPre-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 Interferencefrom 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 Functionfrom 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.