Fragility Fractures of the Pelvis (FFP)

Last updated: December 11, 2024
Sponsor: AO Innovation Translation Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

N/A

Clinical Study ID

NCT04182776
AOFFP
  • Ages > 65
  • All Genders

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 Criteria

Inclusion

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 accordingto the Rommens and Hofmann classification (including fractures of the anteriorpelvic ring involving the anterior lip of the acetabulum not regarded as theacetabular 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 thestandard 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 approvedprocedures for patients who are not able to provide independent writteninformed consent

Exclusion

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, seeabove)

  • Pathological fractures (ie, patients with malignant or metastatic diseases of thepelvis, infections)

  • Concomitant osteoporotic fractures outside of pelvis

  • Participation in any other medical device or medicinal product study within theprevious month that could influence in opinion of the PI the results of the presentregistry

Study Design

Total Participants: 420
Study Start date:
March 01, 2022
Estimated Completion Date:
June 30, 2026

Study Description

More in detail this registry has the following objectives:

  • To identify the difference in patient related outcome comparing the surgical and conservative treatment in patients suffering from an FFP with different levels of pelvic instability at different time points

  • To compare the rate of complications, morbidity and mortality between the different treatment modalities over the whole study period

Connect with a study center

  • The Ottawa Hospital - Civic Campus

    Ottawa,
    Canada

    Active - Recruiting

  • University Medical Center Hamburg Eppendorf

    Hamburg,
    Germany

    Active - Recruiting

  • University Hospital Leipzig

    Leipzig,
    Germany

    Active - Recruiting

  • University Medical Center Johannes Gutenberg-University

    Mainz, 55131
    Germany

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Okayama medical hospital

    Okayama,
    Japan

    Active - Recruiting

  • University Medical Center Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Terminated

  • Cantonal Hospital Lucerne

    Luzern,
    Switzerland

    Active - Recruiting

  • University of Missouri

    Columbia, Missouri 65203
    United States

    Active - Recruiting

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