Clinical trial NCT04182776: Fragility Fractures of the Pelvis (FFP)
Official title: Fragility Fractures of the Pelvis: Observational Outcome Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Fracture
Keywords: Pelvis
Fragility Fracture
Classification
Conservative
Operative
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 420
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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).

Detailed 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

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

Primary outcomes:
measure: Demographics
timeFrame: Pre-treatment
measure: Comorbidities
timeFrame: Pre-treatment
measure: Cognitive status
timeFrame: Pre-treatment
measure: Patient-reported outcomes: PROMIS Pain Interference
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Patient-reported outcomes: PROMIS Physical Function
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Patient Reported Outcomes - EuroQoL (EQ-5D-3L)
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary outcomes:
measure: Parker Mobility Score
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Modified Barthel index
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Residential status
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Mortality
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Radiological outcomes
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Anticipated treatment or condition-related adverse events (i.e. complications)
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
city: Hamburg
country: Germany
facility: University Medical Center Hamburg Eppendorf
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Mainz
country: Germany
facility: University Medical Center Johannes Gutenberg-University
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Okayama
country: Japan
facility: Okayama medical hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Luzern
country: Switzerland
facility: Cantonal Hospital Lucerne
Study officials:
affiliation: University Medical Center Johannes Gutenberg-University
name: Pol Maria Rommens, MD
role: PRINCIPAL_INVESTIGATOR
References: