Fragility Fractures of the Pelvis (FFP)

Pelvic Fracture Clinical Trial

Official title:

Fragility Fractures of the Pelvis: Observational Outcome Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182776
• Other study ID #: AOFFP
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: AO Innovation Translation Center
• Contact: Aleksandra Hodor
• Phone: +41442002481
• Email: Aleksandra.hodor[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Pelvic Fracture

Locations

Country	Name	City	State
Canada	The Ottawa Hospital - Civic Campus	Ottawa
Germany	University Medical Center Hamburg Eppendorf	Hamburg
Germany	University Hospital Leipzig	Leipzig
Germany	University Medical Center Johannes Gutenberg-University	Mainz
Hong Kong	Queen Mary Hospital	Hong Kong
Japan	Okayama medical hospital	Okayama
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Radboud University Medical Center	Nijmegen
Switzerland	Cantonal Hospital Lucerne	Luzern
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Hong Kong,  Japan,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	Year of birth, Gender, Ethnicity, Height (cm) and Weight (kg) will be combined to report BMI in kg/m^2	Pre-treatment
Primary	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.	Pre-treatment
Primary	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.	Pre-treatment
Primary	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.	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Primary	Patient-reported outcomes: PROMIS Physical Function	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.	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Primary	Patient Reported Outcomes - EuroQoL (EQ-5D-3L)	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.	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	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).	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	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.	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	Residential status	The residential status will be documented at each visit during 1-year post-treatment phase.	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	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)	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	Radiological outcomes	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)	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	Anticipated treatment or condition-related adverse events (i.e. complications)	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.	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)