Fragility Fractures of the Pelvis (FFP)

Fragility Fractures of the Pelvis: Observational Outcome Study

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).

Study Overview

• Status: Recruiting
• Conditions: Pelvic Fracture

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 420

Contacts and Locations

• Study Contact: Name: Aleksandra Hodor; Phone Number: +41442002481; Email: Aleksandra.hodor@aofoundation.org

Study Locations

• Canada
  • Ottawa, Canada
    • Recruiting
    • The Ottawa Hospital - Civic Campus
    • Contact: Geoffrey Wilkin
• Germany
  • Hamburg, Germany
    • Recruiting
    • University Medical Center Hamburg Eppendorf
    • Contact: Maximilian Hartel
  • Leipzig, Germany
    • Recruiting
    • University Hospital Leipzig
    • Contact: Philipp Pieroh
  • Mainz, Germany, 55131
    • Not yet recruiting
    • University Medical Center Johannes Gutenberg-University
    • Contact: Pol Maria Rommens, MD
    • Contact: Daniel Wagners, MD
• Hong Kong
  • Hong Kong, Hong Kong
    • Not yet recruiting
    • Queen Mary Hospital
    • Contact: King Hang Dennis Yee
• Japan
  • Okayama, Japan
    • Not yet recruiting
    • Okayama medical hospital
    • Contact: Naofumi Shiota
• Netherlands
  • Groningen, Netherlands
    • Recruiting
    • University Medical Center Groningen
    • Contact: Frank IJpma
  • Nijmegen, Netherlands
    • Terminated
    • Radboud University Medical Center
• Switzerland
  • Luzern, Switzerland
    • Recruiting
    • Cantonal Hospital Lucerne
    • Contact: Matthias Knobe
• United States
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Recruiting
      • University of Missouri
      • Contact: Gregory Della Rocca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pelvis fracture type II to IV; All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. The registry does not dictate any specific treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Year of birth, Gender, Ethnicity, Height (cm) and Weight (kg) will be combined to report BMI in kg/m^2	Pre-treatment
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
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
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Pol Maria Rommens, MD, University Medical Center Johannes Gutenberg-University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Classification; Pelvis; Operative; Conservative; Fragility Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: AOFFP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No