Fragility Fractures of the Pelvis (FFP)

AO Innovation Translation Center

Status: Enrolling

Conditions: Pelvic Fracture

Study type: Observational

Funder types: Other

Identifiers

NCT04182776

AOFFP

Details and patient eligibility

About

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).

Full 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

Enrollment: 420 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

420 participants in 1 patient group

Pelvis fracture type II to IV

Description:

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.