Fragility Fractures of the Pelvis (FFP)

NCT04182776 | Recruiting

• 1 other identifier: AOFFP
• Study Type: observational
• Target: 420
• Locations: 7 countries
• Sites: 10

Brief 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).

Conditions

Pelvic Fracture

Keywords

Pelvis; Fragility Fracture; Classification; Conservative; Operative

Outcome Measures

Primary Outcomes (6)

• Demographics

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

  Pre-treatment

• Comorbidities

  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.

  Pre-treatment

• Cognitive status

  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.

  Pre-treatment

• Patient-reported outcomes: PROMIS Pain Interference

  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.

  from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

• Patient-reported outcomes: PROMIS Physical Function

  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.

  from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

• Patient Reported Outcomes - EuroQoL (EQ-5D-3L)

  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.

  from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

Secondary Outcomes (6)

• Parker Mobility Score

  from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

• Modified Barthel index

  from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

• Residential status

  from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

• Mortality

  from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

• Radiological outcomes

  from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

Study Arms (1)

Pelvis fracture type II to IV

All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. The registry does not dictate any specific treatment.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients (over 65) who have suffered from fragility fractures of the pelvis (FFP), equal to or higher than type II (according to Rommens and Hofmann)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (10)

University of Missouri

Columbia, Missouri, 65203, United States

RECRUITING

The Ottawa Hospital - Civic Campus

Ottawa, Canada

RECRUITING

University Medical Center Hamburg Eppendorf

Hamburg, Germany

RECRUITING

University Hospital Leipzig

Leipzig, Germany

RECRUITING

University Medical Center Johannes Gutenberg-University

Mainz, 55131, Germany

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Okayama medical hospital

Okayama, Japan

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

Radboud University Medical Center

Nijmegen, Netherlands

TERMINATED

Cantonal Hospital Lucerne

Lucerne, Switzerland

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Pol Maria Rommens, MD

  University Medical Center Johannes Gutenberg-University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Hodor

CONTACT

+41442002481; Aleksandra.hodor@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 2, 2019
• Study Start: March 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

JP (1); HK (1); NL (2); US (1); DE (3); CH (1); CA (1)