Assessment of Treatment Variability for Pelvic Ring Fragility Fractures

NCT07351123 | Not Yet Recruiting

• 1 other identifier: 1R01AR086467-01
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pelvic Fractures; Fragility Fractures of the Pelvis (FFP)

Keywords

Pelvic fracture; Fragility fracture of the pelvis; Pelvic ring injury

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  4 months

Study Arms (1)

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

Procedure: Surgical stabilization of pelvic fracture; Other: Closed treatment of pelvic fracture

Interventions

Surgical stabilization of pelvic fracture PROCEDURE

Surgical stabilization of pelvic fracture through placement of orthopaedic hardware.

Patient

Closed treatment of pelvic fracture OTHER

Pelvic fracture that is treated without surgery and assessed over time through interval radiographs until fracture is healed.

Patient

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Mark Gage, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Gage, MD

CONTACT

410-328-1868; mgage@som.umaryland.edu

Heather Phipps, MPS

CONTACT

hphipps@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available to the research community as soon as possible, but no later than one year after publication of the initial study manuscript. All data will be kept in the NTRR for at least five years after the initial study publication.
• Access Criteria: All data and associated study materials will be submitted to the NTRR. The NTRR is built on the Biomedical Research Information Computing System (BRICS) platform developed by the Center for Information Technology at the National Institutes of Health (NIH). The NTRR platform and processes meet the NIH Grant Policy on Sharing of Unique Research Resources, including the Sharing of Biomedical Research Resources Principles and Guidelines for Recipients of the NIH Grants and Contracts. Data will be findable for the research community through the NTRR. The NTRR assigns a unique digital object identifier (DOI) for each data set submitted. This DOI, as a persistent unique identifier, can be used to reference the data set in manuscripts. Data stored in the NTRR meets FAIR principles (findable, accessible, interoperable, and re-usable).