RECRUITING

Fragility Fractures of the Pelvis (FFP)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Fragility Fractures of the Pelvis: Observational Outcome Study

Quick Facts

Study Start:2022-03-01
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04182776

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 65 years or older at time of injury
  2. * 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)
  3. * Informed consent obtained, ie:
  4. * Ability to understand the content of the patient information/ICF
  5. * Willingness and ability to participate in the registry according to the standard of care in each clinic
  6. * Signed and dated Ethics Committee (EC)/ Institutional Review Board (IRB) approved written informed consent OR
  7. * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent
  1. * Pelvic fractures that do not meet the criteria of a fragility fracture (ie, high-energy trauma)
  2. * FFP type I fractures
  3. * Concomitant fractures of the acetabulum (except anterior lip of the acetabulum, see above)
  4. * Pathological fractures (ie, patients with malignant or metastatic diseases of the pelvis, infections)
  5. * Concomitant osteoporotic fractures outside of pelvis
  6. * 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

Contacts and Locations

Study Contact

Aleksandra Hodor
CONTACT
+41442002481
Aleksandra.hodor@aofoundation.org

Principal Investigator

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

Study Locations (Sites)

University of Missouri
Columbia, Missouri, 65203
United States

Collaborators and Investigators

Sponsor: AO Innovation Translation Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01
Study Completion Date2026-06

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Pelvis
  • Fragility Fracture
  • Classification
  • Conservative
  • Operative

Additional Relevant MeSH Terms

  • Pelvic Fracture