Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Frac… (NCT06496867) | Clinical Trial Compass
RecruitingNot Applicable
Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis
United States48 participantsStarted 2024-11-12
Plain-language summary
The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy lateral compression type 1 (LC1) pelvis fracture with \<10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, early internal fixation or nonoperative care with early rehabilitation, defined as at least five days of attempted mobilization by rehabilitation providers. Participants will be followed for 1 year.
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 defined as a fall from standing height.
✓. LC1 pelvis fracture (AO/OTA 61B1.1 or 61B2.1) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
✓. Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.
✓. 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.
✕. 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.