Fragility Fractures of the Pelvis (FFP)
ConditionPelvic Fracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorAO Innovation Translation Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
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
Disqualifiers
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)
Trial 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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
420 Participants
are grouped into 1 trial groupGroup A: Pelvis fracture type II to IV
Trial outcomes
Primary outcomes
1
Demographics
Year of birth, Gender, Ethnicity, Height (cm) and Weight (kg) will be combined to report BMI in kg/m\^2
Time frame
Pre-treatment2
Comorbidities
Concomitant diseases will be assessed using the Charlson Comorbidity Index (CCI). This score assesses the comorbidity level by considering both the number and severity of pre-defined comorbid conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates. It is a 17-items questionnaire with score range from 0 to 37 points. It estimates the 10-year (or shorter) patient survival.
Time frame
Pre-treatment3
Cognitive status
The MiniCog is a 3-minute instrument assessing cognitive impairment. It consists of two components, a 3-item recall test for memory and a simply scored clock drawing test. A total score ranges from 0 to 5. A score of zero, one or two out of five points in total, indicates a concern in cognitive functioning.
Time frame
Pre-treatment4
Patient-reported outcomes: PROMIS Pain Interference
PROMIS (Patient-Reported Outcome Measurement Information System) Pain Interference (8 questions) assesses the impact of pain on common activities of daily life including social, cognitive, emotional, physical, and recreational aspects. The higher score represents a higher pain level.
Time frame
from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)Secondary outcomes
1
Parker Mobility Score
Parker Mobility Scale assess the patient's ability to perform indoor walking, outdoor walking, and shopping before the fracture. A score ranges between 0 and 3 (0 = not at all, 1 = with help from another person, 2 = with an aid, and 3 = no difficulty and no aid) for each function, resulting in a total score ranging from 0 (no walking ability at all) to 9 (fully independent).
Time frame
from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)2
Modified Barthel index
The Barthel index is an ordinal scale and each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses 10 variables describing activities of daily living and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
Time frame
from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)3
Residential status
The residential status will be documented at each visit during 1-year post-treatment phase.
Time frame
from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)4
Mortality
Mortality will be assessed for 4 phases: * Perioperative mortality * Within the first 7 days after treatment (early-term) * Within the first 3 months after treatment (mid-term) * Until the last follow up (long-term mortality)
Time frame
from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)Sponsors and contacts
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Source ClinicalTrials.gov