Not Yet RecruitingNot Applicable

Assessment of Treatment Variability for Pelvic Ring Fragility Fractures

120 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

What they're measuring

Patient Willingness to Enroll in a Trial

Timeframe: 4 months

Surgeon Willingness to Randomize Patient Treatment

Timeframe: 4 months

Completeness of Patient Centered Outcomes Collected

Timeframe: 4 months

Trial details

NCT IDNCT07351123

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-08-31

Contact for this trial

Mark Gage, MD

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

View on ClinicalTrials.gov More Pelvic Fractures trials

Plain-language summary

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.