Fragility Fractures of the Pelvis (FFP)

Launched by AO INNOVATION TRANSLATION CENTER · Nov 27, 2019

Keywords

ClinConnect Summary

The Fragility Fractures of the Pelvis (FFP) clinical trial is studying how pelvic fractures, specifically those classified as type II or higher, affect older patients. The trial will involve around 420 participants aged 65 and older who have suffered these types of fractures. Researchers want to collect information about the patients' medical history, the treatments they receive, and how well they recover over a year. This includes looking at their physical function, any complications that may arise from the treatment, and the results of imaging tests like CT scans.

To be eligible for the trial, participants must be at least 65 years old and have a specific type of pelvic fracture that is not caused by high-energy trauma, such as a car accident. They need to provide informed consent, which means they understand the study and agree to participate. Throughout the study, participants can expect regular follow-ups to monitor their recovery and any side effects related to their treatment. This trial is currently recruiting participants, and it aims to improve our understanding of pelvic fractures in older adults, ultimately helping to enhance their care.

Gender

ALL

Eligibility criteria

• 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