Functional Outcomes in Older Adults With Fragility Fractures of the Pelvis: The FFP-France Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorCentre Hospitalier Universitaire de Nice
About this trial
Fragility fractures of the pelvis (FFP) are an increasingly common complication of osteoporosis in older adults and are associated with substantial morbidity, loss of independence, and mortality. Despite their clinical impact, FFP remain underdiagnosed, particularly sacral fractures, and their management varies considerably across centers.FFP-France is a French multicenter ambispective observational study designed to describe functional outcomes in adults aged 60 years and older with FFP. The primary objective is to assess functional outcome at 6 months using the Parker Mobility Score. Secondary objectives include describing clinical and radiological characteristics, diagnostic and therapeutic management, pain, autonomy, mortality, osteoporosis management, and factors associated with unfavorable functional recovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥60 years.
Fragility fracture of the pelvis occurring spontaneously or following a low energy trauma.
Fracture confirmed by imaging (radiography, computed tomography, magnetic resonance imaging, bone scintigraphy, or positron emission tomography).
Disqualifiers
Pelvic fracture resulting from high-energy trauma.
Pathological fracture secondary to a malignant bone lesion.
Trial population
Adults aged 60 years and older diagnosed with a fragility fracture of the pelvis and managed at participating French centers during the retrospective or prospective study periods.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Observational Assessment of Fragility Fractures of the Pelvis
Other interventionNo study-specific intervention is performed. Diagnostic and therapeutic management is determined by routine clinical practice at each participating center. Clinical, radiological, treatment, and outcome data are collected for observational purposes.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients With Fragility Fractures of the Pelvis1 intervention
Trial outcomes
Primary outcomes
1
Functional Mobility at 6 Months Assessed by the Parker Mobility Score (PMS)
Functional mobility will be assessed using the Parker Mobility Score (PMS), which evaluates the participant's ability to walk indoors, walk outdoors, and go shopping. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 9, with higher scores indicating greater mobility.
Time frame
6 months after the fragility fracture of the pelvisSecondary outcomes
1
Type of Fracture Management
Proportion of patients managed conservatively or interventionally for fragility fracture of the pelvis. Management strategies will be described according to patient characteristics and fracture type, including the Rommens classification
Time frame
From diagnosis to 12 months after the fracture2
Use of Anti-Osteoporotic Treatment
Proportion of patients receiving anti-osteoporotic treatment after the fracture. Anti-osteoporotic treatment before and after the fracture, including treatment initiation, continuation, or modification during follow-up, will be recorded.
Time frame
From diagnosis to 12 months after the fracture3
Recovery of Pre-Fracture Mobility
Proportion of patients who recover their pre-fracture level of mobility at 3 and 12 months, based on the Parker Mobility Score. The Parker Mobility Score ranges from 0 to 9, with higher scores indicating better mobility. Demographic and clinical characteristics, fracture type, fracture management strategy, and osteoporosis management will be investigated as potential factors associated with functional recovery.
Time frame
3 and 12 months after the fracture4
All-Cause Mortality
Proportion of patients who die from any cause during follow-up. Mortality will be assessed at 3, 6, and 12 months after the fracture
Time frame
3, 6, and 12 months after the fractureSponsors and contacts
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Source ClinicalTrials.gov
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