What is the Purpose of this Study?
The purpose of this study is to evaluate whether early surgical treatment is more effective than nonoperative care and early rehabilitation at lowering the risk of complications in patients with pelvis fractures. Both options are commonly used by orthopedic surgeons to treat fractures. Participants in this study will be randomly assigned to 1 of 2 treatment groups. The surgical treatment group will undergo internal fixation, which consists of putting 1 or more metal plates and/or screws in the bone to join the broken pieces of bone. The other group will receive nonoperative treatment with early rehabilitation. The study doctor (surgeon) will work with other health care professionals such as physical therapists to guide rehabilitation with a walking aid (such as a walker). Nonoperative treatment avoids the risks associated with surgery, but it is possible that these patients may need to stay in hospital longer or take longer to remobilize. It is also possible that they would need to have surgery to repair the pelvis fracture if unable to mobilize for an extended period of time.
Eligibility
- 1. Patient 60 years of age or older.
- 2. Low energy injury mechanism defined as a fall from standing height.
- 3. 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.
- 4. Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus NonOperative Care with Early Rehabilitation for LC1 Fragility Fractures of the Pelvis: A Pilot Study