Assessment of Treatment Variability for Pelvic Ring Fragility Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Surgical stabilization of pelvic fracture
- Closed treatment of pelvic fracture
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Maryland, Baltimore
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov