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NCT Number: NCT04182776

Fragility Fractures of the Pelvis (FFP)

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ottawa Hospital - Civic Campus, Ottawa, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Demographics

    Time frame: Pre-treatment

    Year of birth, Gender, Ethnicity, Height (cm) and Weight (kg) will be combined to report BMI in kg/m^2

  2. Comorbidities

    Time frame: Pre-treatment

    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.

  3. Cognitive status

    Time frame: Pre-treatment

    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.

  4. Patient-reported outcomes: PROMIS Pain Interference

    Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

    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.

  5. Patient-reported outcomes: PROMIS Physical Function

    Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

    PROMIS Physical Function (10 questions) assesses self-reported capability of physical activities including instrumental activities of daily living. A higher score indicates a better self-reported capability.

  6. Patient Reported Outcomes - EuroQoL (EQ-5D-3L)

    Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

    The EQ-5D-3L has five items (mobility, self-care, usual activities, pain/discomfort anxiety/depression) with a three-point categorical response scale level (1 = no problems, 2 = some / moderate problems, 3 = extreme problems) where the patient's current health status is assessed. A unique EQ-5D-3L health state is defined by combining one level from each of the five dimensions. The EQ-5D index score ranges from 0 (death) to 1 (best imaginable quality of life), and negative values express "worse than death" state.

Secondary outcomes

  1. Parker Mobility Score

    Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

    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).

  2. Modified Barthel index

    Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

    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.

  3. Residential status

    Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

    The residential status will be documented at each visit during 1-year post-treatment phase.

  4. Mortality

    Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

    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)
  5. Radiological outcomes

    Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

    Position of the fracture fragments, to rule out secondary (additional) fracture fragments and displacement, or loosening of implants (Undisplaced, Displaced, Non-union with extensive callus)

  6. Anticipated treatment or condition-related adverse events (i.e. complications)

    Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

    In this registry, only condition- or treatment-related events (ie complications) will be collected . Partially those events presuppose themselves: eg, re-admission for a surgical revision. In those cases, details on those different events will be collected.

Sponsors and collaborators

Lead sponsor

AO Innovation Translation Center

Other

Registry information

Official study title

Fragility Fractures of the Pelvis: Observational Outcome Study

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2019
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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