Pelvic FracturesPelvis ATVNCT07351123
Assessment of Treatment Variability for Pelvic Ring Fragility Fractures
An observational study of Pelvic Fractures and Fragility Fractures of the Pelvis (FFP), run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Fragility fractures of the pelvic ring are a common injury associated with poor patient outcomes and high healthcare costs. Management of these injuries is evolving with increasing frequency of operative stabilization of the pelvic ring, despite a lack of evidence supporting operative versus nonoperative treatment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pelvic Fractures, Fragility Fractures of the Pelvis (FFP)
- What is being tested?
- Surgical stabilization of pelvic fracture and Closed treatment of pelvic fracture
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2026to 30 Sep 2027
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥ 60 years of age with a closed pelvic ring fracture with an anterior and posterior injury observable on x-ray or CT scan.
The inclusion criteria are:
- Patient 60 years of age or older.
- Low energy injury mechanism.
- LC1 pelvis fracture (AO/OTA 61B1.1,61B2.1, or 61B3.2) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
- Fracture displacement of <10 mm of the posterior pelvic ring on computed tomography of the pelvis.
- Injury occurred within 21 days of screening.
The exclusion criteria are:
- Patient did not ambulate prior to injury.
- Severely frail patients (Clinical Frailty Scale ≥7).
- Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
- Retained implants around the pelvis that precludes or limits either study treatment.
- Infection around the hip (soft tissue or bone).
- Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
- Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
- Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Expected injury survival of less than 12 months.
- Terminal illness with expected survival of less than 12 months.
- Currently enrolled in a study that does not permit co-enrollment.
- Prior enrollment in the study.
- Unable to obtain informed consent due to language barriers.
- Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
- Did not provide informed consent (declined participation).
- Patient or LAR not approached to participate in the trial (missed patient).
- Other reason to exclude the patient, as approved by the Principal Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Heather Phipps, MPS contact
United States1 site, 1 recruiting
- Recruiting
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Allyson Curtis, 4107061239, allyson.curtis@som.umaryland.edu
About this study
Fragility fractures of the pelvic ring are a common injury associated with poor patient outcomes and high healthcare costs. Management of these injuries is evolving with increasing frequency of operative stabilization of the pelvic ring, despite a lack of evidence supporting operative versus nonoperative treatment. This multicenter prospective cohort study will evaluate 120 patients to determine the feasibility of a randomized controlled trial comparing operative and nonoperative treatment, by evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.
Read the detailed description
Fragility fractures of the pelvic ring are a common injury that is increasing in incidence with an aging population. These injuries are associated with high healthcare costs and poor patient outcomes, including decline in ambulatory function, decreased independence, and a one-year mortality of 11-27%. Historically, older adults with fragility fractures of the pelvis received nonoperative treatment with supportive care because operative management was deemed too invasive for this patient population. However, the development of percutaneous and less invasive surgical techniques has led to an increased frequency of operative stabilization of pelvis fractures in older adults. It is unclear if the increasing use of surgical fixation is improving outcomes for patients with pelvic fragility fractures. There are significant limitations with the current body of evidence that precludes its ability to guide clinical practice. Randomized controlled trials testing the efficacy of operative management are urgently needed to determine when surgical fixation is warranted.
Two pilot randomized controlled trials have been performed on this patient population, and both have not progressed to a definitive study citing a lack of recruitment feasibility. This is due to both the lack of agreement amongst surgeons for which patients should receive randomized treatment, as well as a lack of patient willingness to enroll in a trial. Furthermore, loss to follow up is a concern in both the orthopaedic trauma population and in older adult study patients. This prospective cohort study will evaluate 120 patients from six hospitals to determine the feasibility of a randomized controlled trial (RCT) comparing operative versus nonoperative management of fragility fractures of the pelvic ring. This will be accomplished by three aims evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.
- Being tested
- Surgical stabilization of pelvic fracture, Closed treatment of pelvic fracture
- Keywords
- Pelvic fracture, Fragility fracture of the pelvis, Pelvic ring injury
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical stabilization of pelvic fractureProcedure or surgery
Surgical stabilization of pelvic fracture through placement of orthopaedic hardware.
Closed treatment of pelvic fractureOther
Pelvic fracture that is treated without surgery and assessed over time through interval radiographs until fracture is healed.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients aged 60 years and older with a low energy mechanism closed pelvic ring fracture with an anterior and posterior injury observable on x-ray or CT scan Receives: Procedure: Surgical stabilization of pelvic fracture; Other: Closed treatment of pelvic fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Willingness to Enroll in a Trial
Willingness to enroll in a trial will be assessed as a binary variable with the central three choices representing that the participant is willing to have their treatment randomized.
Measured: 4 months
Surgeon Willingness to Randomize Patient Treatment
Surgeon willingness to enroll the patient in the trial will be assessed as a binary variable with the central three choices representing that the surgeon would have been willing to have their treatment decision randomized.
Measured: 4 months
Completeness of Patient Centered Outcomes Collected
The outcome measure completion will be assessed as a binary variable classified as either complete documentation or missing documentation.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start25 May 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FracturesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Mark Gage, University of Maryland, Baltimore
- Investigators
- Mark Gage, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351123
- Sponsor's protocol ID
- 1R01AR086467-01
- Other IDs
- 1R01AR086467-01
- Acronym
- Pelvis ATV
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Final Research Data set of validated de-identified data will include discrete data elements supporting the primary and secondary endpoints. Demographic, injury, clinical results data will be acquired from pelvis fracture subjects. All data will be de-identified prior to receipt by the National Trauma Research Repository (NTRR).
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Treatment Variability for Pelvic Ring Fragility Fractures
- ClinicalTrials.gov ID
- NCT07351123
- Acronym / sponsor ID
- Pelvis ATV / 1R01AR086467-01
- Keywords
- Pelvic fracture, Fragility fracture of the pelvis, Pelvic ring injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 25 May 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
Fragility fractures of the pelvic ring are a common injury associated with poor patient outcomes and high healthcare costs. Management of these injuries is evolving with increasing frequency of operative stabilization of the pelvic ring, despite a lack of evidence supporting operative versus nonoperative treatment. This multicenter prospective cohort study will evaluate 120 patients to determine the feasibility of a randomized controlled trial comparing operative and nonoperative treatment, by evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.
Detailed description
Fragility fractures of the pelvic ring are a common injury that is increasing in incidence with an aging population. These injuries are associated with high healthcare costs and poor patient outcomes, including decline in ambulatory function, decreased independence, and a one-year mortality of 11-27%. Historically, older adults with fragility fractures of the pelvis received nonoperative treatment with supportive care because operative management was deemed too invasive for this patient population. However, the development of percutaneous and less invasive surgical techniques has led to an increased frequency of operative stabilization of pelvis fractures in older adults. It is unclear if the increasing use of surgical fixation is improving outcomes for patients with pelvic fragility fractures. There are significant limitations with the current body of evidence that precludes its ability to guide clinical practice. Randomized controlled trials testing the efficacy of operative management are urgently needed to determine when surgical fixation is warranted.
Two pilot randomized controlled trials have been performed on this patient population, and both have not progressed to a definitive study citing a lack of recruitment feasibility. This is due to both the lack of agreement amongst surgeons for which patients should receive randomized treatment, as well as a lack of patient willingness to enroll in a trial. Furthermore, loss to follow up is a concern in both the orthopaedic trauma population and in older adult study patients. This prospective cohort study will evaluate 120 patients from six hospitals to determine the feasibility of a randomized controlled trial (RCT) comparing operative versus nonoperative management of fragility fractures of the pelvic ring. This will be accomplished by three aims evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Procedure: Surgical stabilization of pelvic fracture, Other: Closed treatment of pelvic fracturePatients aged 60 years and older with a low energy mechanism closed pelvic ring fracture with an anterior and posterior injury observable on x-ray or CT scan |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 60 years of age with a closed pelvic ring fracture with an anterior and posterior injury observable on x-ray or CT scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical stabilization of pelvic fractureSurgical stabilization of pelvic fracture through placement of orthopaedic hardware. | Procedure or surgery | Patient |
| Closed treatment of pelvic fracturePelvic fracture that is treated without surgery and assessed over time through interval radiographs until fracture is healed. | Other | Patient |
Primary outcome
Patient Willingness to Enroll in a Trial
Time frame: 4 months
Willingness to enroll in a trial will be assessed as a binary variable with the central three choices representing that the participant is willing to have their treatment randomized.
Surgeon Willingness to Randomize Patient Treatment
Time frame: 4 months
Surgeon willingness to enroll the patient in the trial will be assessed as a binary variable with the central three choices representing that the surgeon would have been willing to have their treatment decision randomized.
Completeness of Patient Centered Outcomes Collected
Time frame: 4 months
The outcome measure completion will be assessed as a binary variable classified as either complete documentation or missing documentation.
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 8 Jun 2026.
- Individual participant dataSharing planned: Yes. The Final Research Data set of validated de-identified data will include discrete data elements supporting the primary and secondary endpoints. Demographic, injury, clinical results data will be acquired from pelvis fracture subjects. All data will be de-identified prior to receipt by the National Trauma Research Repository (NTRR).
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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.
Heather Phipps, MPS contact
Mark Gage, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fractures and Fragility Fractures of the Pelvis (FFP), run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Contact Mark Gage, MD (410-328-1868, mgage@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Willingness to Enroll in a Trial (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.