Pilot study on treatment options for minimally displaced femoral neck fractures in older adults
Multicenter Randomized Controlled Trial Comparing Hip Arthroplasty to Internal Fixation for Minimally Displaced Femoral Neck Fractures: A Pilot Study
This study is testing two different surgical options for treating hip fractures in older adults to see which one helps them recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Trial ID | NCT05947058 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of a definitive trial comparing two surgical treatments for minimally displaced femoral neck fractures in adults aged 60 and older. Participants will be randomly assigned to receive either hip arthroplasty or internal fixation, with follow-up for one year to assess outcomes. The study seeks to gather data that could inform a larger trial, potentially leading to a significant shift in clinical practice regarding the treatment of these fractures. The focus is on improving patient outcomes and reducing complications associated with current treatment methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 years or older with a low-energy, minimally displaced femoral neck fracture that can be treated surgically.
Not a fit: Patients who are unable to ambulate pre-injury or have associated injuries that prevent post-operative weightbearing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for elderly patients with minimally displaced femoral neck fractures.
How similar studies have performed: Preliminary data suggest that arthroplasty may offer better outcomes for similar conditions, but this specific approach is still being evaluated for its feasibility.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 11 other locations
- University of Southern California — Los Angeles, California, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- University of Maryland, R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States (Recruiting)
- University of Maryland Capital Region Health — Largo, Maryland, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
- Inova Fairfax Medical Campus — Falls Church, Virginia, United States (Recruiting)
- University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
- Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Vall d'Hebron University Hospital — Barcelona, Spain (Enrolling_by_invitation)
Study contacts
- Principal investigator: Gerard Slobogean, MD — University of Maryland, Baltimore
- Study coordinator: Heather Phipps, MPS
- Email: hphipps@som.umaryland.edu
- Phone: 410-706-2492
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.