NCT07351123 · University of Maryland, Baltimore
Assessment of Treatment Variability for Pelvic Ring Fragility Fractures
(Pelvis ATV)
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Surgical stabilization of pelvic fracture
Surgical stabilization of pelvic fracture through placement of orthopaedic hardware.
OTHER
Closed treatment of pelvic fracture
Pelvic fracture that is treated without surgery and assessed over time through interval radiographs until fracture is healed.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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.
Where
- Baltimore, Maryland
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations