Observational study on pelvic fractures in older adults
Fragility Fractures of the Pelvis: Observational Outcome Study
This study looks at how different treatments for pelvic fractures in older adults affect their recovery and complications over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | AO Innovation Translation Center Academic / other |
| Locations | 10 sites (Columbia, Missouri and 9 other locations) |
| Trial ID | NCT04182776 on ClinicalTrials.gov |
What this trial studies
This study collects prospective data from approximately 420 patients aged 65 and older who have suffered from fragility fractures of the pelvis classified as type II or higher. The research aims to compare patient-reported outcomes and complications between surgical and conservative treatment approaches over a follow-up period of up to one year. Data will include details on underlying diseases, treatment methods, functional outcomes, and any adverse events related to the procedures. The goal is to better understand the impact of different treatment modalities on recovery and complications.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 years or older with a confirmed diagnosis of fragility fractures of the pelvis type II or higher.
Not a fit: Patients with pelvic fractures resulting from high-energy trauma or those with type I fractures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for older adults with pelvic fractures, leading to better recovery outcomes.
How similar studies have performed: Other studies have shown success in comparing treatment modalities for pelvic fractures, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbia, Missouri and 9 other locations
- University of Missouri — Columbia, Missouri, United States (Recruiting)
- The Ottawa Hospital - Civic Campus — Ottawa, Canada (Recruiting)
- University Medical Center Hamburg Eppendorf — Hamburg, Germany (Recruiting)
- University Hospital Leipzig — Leipzig, Germany (Recruiting)
- University Medical Center Johannes Gutenberg-University — Mainz, Germany (Recruiting)
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
- Okayama medical hospital — Okayama, Japan (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Radboud University Medical Center — Nijmegen, Netherlands (Terminated)
- Cantonal Hospital Lucerne — Lucerne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Pol Maria Rommens, MD — University Medical Center Johannes Gutenberg-University
- Study coordinator: Aleksandra Hodor
- Email: Aleksandra.hodor@aofoundation.org
- Phone: +41442002481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.