New method for fixing femoral fractures
Official title: Utilizing the Retrograde Femoral Nail-Advanced for Fixation of Distal Femur and Femoral Shaft Fractures: A Prospective Case Series
Run by University of California, San Diego · NCT05680987 · Data updated 2026-11-12
This study is testing a new type of implant for fixing femur fractures in adults to see if it helps them heal better and have fewer complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Status | Recruiting |
| Started | June 23, 2021 |
| Main results expected | June 23, 2026 |
| Study ends | June 23, 2026 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT05680987 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a distal femur or femoral shaft fracture requiring surgical intervention.
✕Probably not a fit
Patients with severe systemic diseases or those for whom alternative fixation methods are deemed more appropriate may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project involves a prospective and retrospective case series design focusing on patients aged 18 and older with distal femur or femoral shaft fractures requiring surgical fixation. Participants will receive the RFN-advanced Retrograde Femoral Nailing System implant, and data on their functional status, healing rates, complication rates, and pain levels will be collected over three years. The goal is to evaluate the effectiveness of this new design in reducing complications associated with current femoral nail systems.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing outcomes and reduced complications for patients with femoral fractures.
How similar studies have gone: While this approach is novel, previous studies have indicated the need for improved fixation methods due to high complication rates with existing designs.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Distal femur or femoral shaft fracture requiring surgery * Evaluation and treatment at UCSD * Age 18 years or older * Ability to understand the content of the patient information/Informed Consent Form * Signed and dated IRB-approved written informed consent Exclusion Criteria: * Any not medically managed severe systemic disease * their doctor has decided that it is in the patient's best interest to receive a different method of fixation * Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study * Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it * Prisoner * Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study
Where it's running
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University of California, San Diego
San Diego, California, United States Recruiting
Study contacts
- Study coordinator: Dominic Baun, MS
- Email: jbaun@health.ucsd.edu
- Phone: 858-534-8268
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Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.