Pelvic FractureNCT04182776
Fragility Fractures of the Pelvis (FFP)
An observational study of Pelvic Fracture, run by AO Innovation Translation Center at 10 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pelvic Fracture
- How many people
- 420 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 1 Mar 2022to Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Germany3 sites
University Medical Center Hamburg Eppendorf
Hamburg
University Hospital Leipzig
Leipzig
University Medical Center Johannes Gutenberg-University
Mainz, 55131
Netherlands2 sites
University Medical Center Groningen
Groningen
Radboud University Medical Center
Nijmegen
About this study
Official title: 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).
Read the 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
- Conditions
- Pelvic Fracture
- Keywords
- Pelvis, Fragility Fracture, Classification, Conservative, Operative
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Year of birth, Gender, Ethnicity, Height (cm) and Weight (kg) will be combined to report BMI in kg/m^2
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Mar 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pol Maria Rommens, MD, Principal investigator, University Medical Center Johannes Gutenberg-University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182776
- Sponsor's protocol ID
- AOFFP
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2019
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rommens PM, Joeris A, Boudissa M, Della Rocca GJ, Fang C, Hartel MJ, Ijpma FF, Link BC, Nasir A, Pieroh P, Shiota N, Wilkin G, Wagner D. Fragility fractures of the pelvis in the elderly: protocol for an international prospective multicentre observational cohort study. BMJ Open. 2026 Sep 17;16(9):e120446. doi: 10.1136/bmjopen-2026-120446.
PubMed 42754272
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fragility Fractures of the Pelvis: Observational Outcome Study
- ClinicalTrials.gov ID
- NCT04182776
- Acronym / sponsor ID
- AOFFP
- Conditions
- Pelvic Fracture
- Keywords
- Pelvis, Fragility Fracture, Classification, Conservative, Operative
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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)
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
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.
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.
6 secondary outcomes
Parker Mobility Score
Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Modified Barthel index
Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Residential status
Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Mortality
Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Radiological outcomes
Time frame: 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)
Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 42754272Rommens PM, Joeris A, Boudissa M, Della Rocca GJ, Fang C, Hartel MJ, Ijpma FF, Link BC, Nasir A, Pieroh P, Shiota N, Wilkin G, Wagner D. Fragility fractures of the pelvis in the elderly: protocol for an international prospective multicentre observational cohort study. BMJ Open. 2026 Sep 17;16(9):e120446. doi: 10.1136/bmjopen-2026-120446.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pol Maria Rommens, MD principal investigator
University Medical Center Johannes Gutenberg-University
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fracture, run by AO Innovation Translation Center at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Netherlands, United States, Canada, Hong Kong and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: Pre-treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04182776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.