Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
NCT05367505
Femoral Fractures, Fractures, Bone
Bad Kreuznach, Germany
View Trial DetailsNCT Number: NCT04182776
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).
This study is active but is not currently recruiting participants.
Notify Me65 year and older
All sexes
Observational
The Ottawa Hospital - Civic Campus, Ottawa, Canada
More in detail this registry has the following objectives:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Pre-treatment
Year of birth, Gender, Ethnicity, Height (cm) and Weight (kg) will be combined to report BMI in kg/m^2
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.
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.
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.
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.
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.
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).
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.
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.
Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Mortality will be assessed for 4 phases:
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)
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.
AO Innovation Translation Center
Other
Fragility Fractures of the Pelvis: Observational Outcome Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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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