Minimally Displaced Femoral Neck Fracture Pilot Study

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jul 11, 2023

Keywords

ClinConnect Summary

The "Minimally Displaced Femoral Neck Fracture Pilot Study" is a research project aimed at understanding the best ways to treat a specific type of hip fracture in older adults. This study is looking for patients aged 60 and older who have experienced a low-energy fracture of the femoral neck, which often happens from a simple fall. Participants will be randomly assigned to one of two treatment options: hip arthroplasty (joint replacement) or internal fixation (using screws or plates to hold the bone together). The goal is to gather information that will help design a larger, more definitive study in the future.

To be eligible, patients must be able to walk at least 10 feet before their injury and have a specific type of fracture confirmed by medical imaging. They should also be in good enough health for surgery, and consent must be obtained from them or a family member. Throughout the year following their treatment, participants will be monitored to see how well they recover. This study is currently recruiting participants and aims to improve care for older adults with this common injury.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients 60 years of age or older.
• • Complete fracture of the femoral neck (AO/OTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
• • Minimally displaced fracture that could be, in the judgment of the attending surgeon, optimally managed with either arthroplasty or in situ internal fixation without reduction.
• • Low energy injury mechanism defined as a fall from standing height.
• • Informed consent obtained from patient or proxy.
• • Surgeons with expertise in total hip arthroplasty, hemiarthroplasty, and internal fixation are available to perform surgery. Note: Surgeons do not need to be experts in all techniques.
• Exclusion Criteria:
• • Unable to ambulate 10 feet pre-injury with any assistance.
• • Associated lower extremity injury that prevents post-operative weightbearing.
• • Retained hardware around the hip that precludes either study treatment.
• • Infection around the hip (soft tissue or bone).
• • Pathologic fracture with a lytic lesion in the femoral neck 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 arthroplasty.
• • Unable to obtain informed consent due to language barriers.
• • Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
• • Currently enrolled in a study that does not permit co-enrollment.
• • Prior enrollment in the trial.
• • Other reason to exclude the patient, as approved by the Methods Centre.